BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALL-IN-ONE CCU+LIGHT ROW

    MDR report key: 9373308 · Received November 25, 2019

    Report

    Report Number
    1221934-2019-59777
    Event Type
    Malfunction
    Date Received
    November 25, 2019
    Date of Event
    November 15, 2019
    Report Date
    November 15, 2019
    Manufacturer
    MEDOS INTERNATIONAL SàRL
    Product Code
    FCW
    UDI-DI
    10886705028702
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H10 ADDITIONAL NARRATIVE: THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE RELIABILITY ENGINEERING EVALUATES THE DEVICE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS RECEIVED AT THE SERVICE CENTER AND EVALUATED. THE SALES REP REPORTED AN ISSUE OF THE CAMERA PICTURE SHOWING UP INTERMITTENTLY. PER SERVICE OPERATIONAL AND DIAGNOSTIC, THIS COMPLAINT CAN BE CONFIRMED. THE ISSUE WAS RESOLVED BY RE-INSTALLING THE SOFTWARE. AFTER REPAIR, THE DEVICE WAS FOUND TO BE WORKING ACCORDING TO THE SPECIFICATIONS. SINCE THE DEVICE WORKED FINE AFTER RE-INSTALLING THE SOFTWARE, THE ISSUE WITH THE INITIALLY INSTALLED SOFTWARE WOULD BE THE ROOT CAUSE OF THE REPORTED PROBLEM. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE FINISHED DEVICE SERIAL NUMBER ((B)(6)), AND THE CERTIFICATE OF CONFORMANCE STATED THAT THE DEVICE WAS MANUFACTURED IN COMPLIANCE WITH THE QUALITY SYSTEM RELEASE CRITERIA. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD. UDI:(B)(4).

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UDI: (B)(4).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED THE CASE WAS COMPLETED USING THE SAME DEVICE. HE REPORTED THE DEVICE CONTINUED TO WORK THROUGH THE CASE AND ISSUES DID NOT ARISE. THE AFFILIATE ALSO REPORTED AN ALTERNATIVE DEVICE WAS NOT AVAILABLE AND SURGICAL INTERVENTION WAS NOT REQUIRED.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UDI: (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY THE SALES REP VIA EMAIL, PRODUCT COMPLAINT INFORMATION: PRODUCT CODE: 242302. PRODUCT SERIAL NUMBER: (B)(4). DESCRIBE THE ISSUE: CAMERA PICTURE SHOWING UP INTERMITTENTLY. IS A REPLACEMENT NEEDED(Y/N: YES. WAS THIS USED IN SURGERY (Y/N): YES. WAS THE PATIENT AFFECTED IN ANY WAY? IF ¿YES¿ PLEASE DESCRIBE: NO. WAS THERE A DELAY IN THE SURGERY? IF ¿YES¿ PLEASE DESCRIBE: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1165903 ALL-IN-ONE CCU+LIGHT ROW ENDOSCOPIC VIDEO IMAGING SYSTEM FCW MEDOS INTERNATIONAL SàRL 242302 10886705028702

    Patients

    Seq Age Sex Outcome Treatment
    1