BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHUMACHER BIOPSY/RNGURLRG-TPSTR240MM

    MDR report key: 12755836 · Received November 6, 2021

    Report

    Report Number
    9610612-2021-00692
    Event Type
    Injury
    Date Received
    November 6, 2021
    Report Date
    January 27, 2022
    Manufacturer
    AESCULAP AG
    Product Code
    HFB
    UDI-DI
    04038653154845
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION/ADDITIONAL INFORMATION: B1 + B2: ADVERSE EVENT. B5: PATIENT HARM CHANGED. H1: SERIOUS INJURY. H6: CODES. INVESTIGATION RESULTS: VISUAL INVESTIGATION: THE FORCEPS IS IN A USED CONDITION, THE DRIVING PIN OF THE MOVABLE HANDLE IS BROKEN UP AND IS REMAINING IN THE UPPER SLIDER. VIGILANCE INVESTIGATOR CARRIED OUT THE PICTORIAL DOCUMENTATION VISUALLY AND MICROSCOPICALLY. THE DRIVING PIN OF THE HANDLE IS BROKEN OFF. THE ANALYSIS OF THE FRACTURE PATTERN ILLUSTRATED A FORCED FRACTURE DUE TO OVERLOAD, E.G. DURING HANDLING OR REPROCESSING. NO PORES, INCLUSIONS OR FOREIGN BODIES COULD BE FOUND ON THE POINT OF RUPTURE. BATCH HISTORY REVIEW: DUE TO THE FACT THAT NO LOT NUMBER WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE COMPLAINED DEVICE IS NOT POSSIBLE. THE REVIEW OF RISK ASSESSMENT REVEALED THAT THE OVERALL RISK LEVEL (SEVERITY 3(5) X PROBABILITY OF OCCURRENCE 2(5)) ACCORDING TO DIN EN ISO 14971 IS STILL ACCEPTABLE. CONCLUSION AND MEASURES / PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS A CLEAR ROOT CAUSE CONCLUSION CANNOT BE DRAWN. THERE IS NO INDICATION FOR A MATERIAL-, MANUFACTURING- OR DESIGN-RELATED FAILURE. BASED UPON THE INVESTIGATIONS RESULTS A CAPA IS NOT NECESSARY.

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    CORRECTION/ADDITIONAL INFORMATION: PATIENT HARM CHANGED TO ADDITIONAL MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO AESCULAP (B)(4) THAT A SHUMACHER BIOPSY/RNGURLRG-TPSTR240MM (PART # ER064R) WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, ONE OF THE FORCEPS' ARMS FRACTURED WHILE ATTEMPTING TO EXTRACT SAMPLES FROM THE CERVIX. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE MALFUNCTION IS FILED UNDER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1653886 SHUMACHER BIOPSY/RNGURLRG-TPSTR240MM GENERAL SURGICAL INSTRUMENTS HFB AESCULAP AG ER064R 04038653154845

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention