BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTERY FORCEPS CURVED 225MM

    MDR report key: 10133269 · Received June 9, 2020

    Report

    Report Number
    9610612-2020-00204
    Event Type
    Malfunction
    Date Received
    June 9, 2020
    Report Date
    April 12, 2021
    Manufacturer
    AESCULAP AG
    Product Code
    HRQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ASSOCIATED MEDWATCH REPORT 9610612-2020-00205 (400472739 BC606R). GENERAL INFORMATION WE RECEIVED A COMPLAINT ABOUT AN ARTERY FORCEPS, NOTICED DURING INCOMING GOODS INSPECTION. DUE TO COVID-19, THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION, BUT A PICTURE PROVIDED BY SALES ORGANIZATION. CONSEQUENCES FOR THE PATIENT ACCORDING TO THE AVAILABLE INFORMATION, THERE WERE NO NEGATIVE CONSEQUENCES FOR THE PATIENT (INCOMING GOODS INSPECTION AT THE CUSTOMER). FAILURE DESCRIPTION BASED ON THE PROVIDED PICTURE, BURRS AND DEVIATIONS OF THE SHAPE CAN BE FOUND AT THE WORKING END. INVESTIGATION INVESTIGATION WAS CARRIED OUT BASED ON THE PROVIDED PICTURE. UNFORTUNATELY THE MAGNIFICATION IS UNKNOWN. NEVERTHELESS, THE SHAPE OF THE SERRATION IS MOST LIKELY NOT ACCORDING TO THE INTERNAL SPECIFICATIONS N-076014. BURRS CAN BE FOUND ON TOP OF THE TEETH AND DIFFERENT DISTANCES BETWEEN THE TEETH ARE RECOGNIZABLE. ACCORDING TO THE INTERNAL QUALITY STANDARD, THE SURFACE MUST BE FREE OF BURRS AND SHARP EDGES. FOR FURTHER INVESTIGATIONS, THE PRODUCT IS REQUIRED FOR EXAMINATION. BATCH HISTORY REVIEW THE TRACEABILITY OF ARTICLES WITHOUT BATCH MANAGEMENT REQUIREMENT IS GUARANTEED BY THE PRODUCTION ORDER NUMBER, WHICH CAN BE TRACED OVER THE PRODUCTION PERIOD AND THE CORRESPONDING CUSTOMER (BACKTRACK). IN ADDITION, THE RAW MATERIALS, SEMI-FINISHED PARTS, ETC. USED FOR THE ORDER ARE DOCUMENTED IN THE MANUFACTURING HISTORY RECORDS (DHR - DEVICE HISTORY RECORDS). THIS ENSURES THE TRACEABILITY OF THE INTERNAL SUPPLY AND PRODUCTION CHAIN. INTERNAL TRACEABILITY IS THUS GUARANTEED. CONCLUSION AND ROOT CAUSE BASED ON THE INFORMATION AVAILABLE AS WELL AS A RESULT OF OUR INVESTIGATION THE ROOT CAUSE OF THE FAILURE IS MOST PROBABLY RELATED TO A MANUFACTURING ERROR. RATIONALE REFER TO INVESTIGATION. CORRECTIVE ACTION ACCORDING TO SOP SA-DE13-M-4-2-04-000-0 (CORRECTIVE ACTION AND PREVENTIVE ACTION), A CAPA IS NOT NECESSARY. SINCE THERE IS NO OTHER SIMILAR COMPLAINT LISTED, NO SYSTEMATIC ERROR WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    BASED UPON NEW INFORMATION RECEIVED, THIS EVENT WAS RE-EVALUATED AND IS CONSIDERED NO LONGER REPORTABLE - NO MALFUNCTION OR SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WA

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE PRODUCT ARTERY FORCEPS CURVED 225MM. SPECIFICALLY, IT WAS REPORTED THAT THE FORCEPS EXHIBITED BURRS ON SERRATION AND FRAGMENTING. THE DEFECT WAS DETECTED DURING INCOMING INSPECTION. THERE WAS NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AS OF THE DATE OF THIS REPORT. (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2020-00205 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596365 ARTERY FORCEPS CURVED 225MM GENERAL SURGICAL INSTRUMENTS HRQ AESCULAP AG BH814R UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1