File # PCR

Complaint Investigation
Page: 1 REPORT Date Cat. No. Lot No.

of 4

Investigators (list all investigators):

Reported Event:

Components Returned:
Y Y Qty N Original labeling/packaging returned? N N/A Original labeling/packaging matches the complaint report. (If applicable) Devices or components received

Visual Examination of Returned Product:

Received for evaluation was:

Physical Measurements Taken:

Actual: P F Specification:

Comments: N/A The defect is detected by visual inspection.

Functional Testing Conducted:

Actual: Comments: N/A The defect is detected by visual inspection. P F Specification:

Device History Record Review: This section to be completed by QA Engineer

Mfg date: Exp. Date: N/A Lot number not provided Y N Any relevant rejects? (If yes, provide explanation)

File # PCR

Complaint Investigation
Page: 2 REPORT Date Cat. No. Lot No.

of 4

Investigators (list all investigators):

Y N All QC testing during the manufacturing of this lot that may relate specifically to complaint

passed? (If no , provide explanation) Any CURRENTLY OPEN or PREVIOUSELY GENERATED (within the past year) Deviation Reports (NCMRs), Temporary Change Notices (TCNs) or Corrective or Preventive Actions (CAPAs) that may relate specifically to the complaint mode? (If yes, provide explanation) Completed by QAE or designee: (Initial and date): _______________ Prior Complaints: Y N Have other complaints been issued against this lot for the same issue? (If yes, explain) N/A _ Y N

Comments:

N Have prior complaints been confirmed for the same manufacturing defect for this product

within the past 12 months? (If yes, provide complaint number(s)) Comments:

Cine Film Findings:

N/A Not provided Provided Results of Cine Review:

Risk Evaluation Review:

Y N Does the reported issue present a previously unrecognized/new hazard? If yes, the situation must be evaluated for corrective action through a revision of the risk assessment documentation. Any decision not to take action must be justified within the Corrective Action section of this form. Yes Yes No - Does the Labeling/IFU address the reported issue? Rationale/Result of this review: No Did the labeling, packaging or inadequacy in the IFU contribute to the complaint? Rationale/Result of this review:

Complaint Investigation Summary:

File # PCR

Complaint Investigation
Page: 3 REPORT Date Cat. No. Lot No.

of 4

Investigators (list all investigators):

Investigation Conclusion/Root Cause Determination:

1. Does the Visual Examination suggest the product was manufactured outside specification? Yes No N/A 2. Do the Physical Measurements suggest the product was manufactured outside specification? Yes No N/A 3. Does the Functional Testing suggest the product was manufactured outside specification? Yes No N/A 4. Does the Device History Record suggest the product was manufactured outside specification? Yes No N/A _______________________________________________________________________________________________ A Health Hazard Analysis Decision and Assessment must be performed if: - Any of the above four questions were answered Yes - The complaint is MDR reportable. Rationale/Result of this review (attach supportive documents as appropriate): N/A Is there a possibility of other lots/batches internal/external being affected? Rationale/Result of this review: N/A Yes No

___________________________________________________________________________________________ ____ Root Cause Determination and Rationale:

Corrective Action: This section to be completed by QA Engineer

Y N Is Corrective Action required based on the findings of this investigation?

If Yes, provide the description of corrective action taken (DCR, training, etc.) Y N - Is escalation to gCAPA required based on the findings?

If Yes, provide the gCAPA number If No, provide clear and detailed justification for no corrective action (include CAPA #/DCR # SA # etc. if applicable) Comments: Completed by QAE : (Initial and date): Y Y ______________

N Were Manufacturing Personnel Notified? N Does the complaint investigation change the original MDR or Vigilance Decision?

File # PCR

Complaint Investigation
Page: 4 REPORT Date Cat. No. Lot No.

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Investigators (list all investigators):

Conclusion Code:
Complaint is:
C C1 C2 C3 C4 C5 C6 C7 I I2 U Confirmed Confirmed Manufacturing Confirmed User Confirmed Damage in Transit Confirmed Design Confirmed Misuse Confirmed Exceeded its Design Expectation. Confirmed Supplier Manufacturing Inconclusive Inconclusive No product returned (NPR) Unconfirmed

Confirmed: Evaluation of returned device confirms the reported alleged deficiency of the device Unconfirmed: Evaluation of returned device does not confirm the reported alleged deficiency of the device Inconclusive: Unable to confirm/unconfirm the alleged deficiency of the device

Conclusion Summary:

We have entered this complaint into our database and we continually monitor for any adverse trends that would indicate degradation in product performance.

Reviewer Signatures:
Print Name Signature Date

Photographs: