BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANDLE WITH RATCHET FOR 3.5MM INSTR.

    MDR report key: 15064849 · Received July 20, 2022

    Report

    Report Number
    9610612-2022-00202
    Event Type
    Injury
    Date Received
    July 20, 2022
    Date of Event
    June 30, 2022
    Report Date
    September 19, 2022
    Manufacturer
    AESCULAP AG
    Product Code
    GEI
    PMA / PMN Number
    K940936
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    INVESTIGATION: VISUAL INSPECTION: INSPECTION WAS MADE OF THE SINGLE PARTS. NO PART SEEMS BROKEN. IN THE NEXT STEP WE TRIED TO ASSEMBLE THE HANDLE AGAIN. WE FOUND THAT THE PIN WHICH SHOULD CONNECT THE TWO HALVES OF THE HANDLE AND WHICH WAS TO CREATE AN INTERFERENCE FIT, SLID THROUGH THE HOLES WITHOUT ANY SIGNIFICANT RESISTANCE. SO WE INVESTIGATED THE DRAWINGS OF THE SINGLE PARTS OF THE HANDLE. HERE WE FOUND THAT THE HOLE HAD A SPECIFIC DIAMETER, AND THE DIAMETER OF THE PIN FOR THE JUNCTION. IN THE NEXT STEP WE MEASURED THE DIAMETER OF THE ENCLOSED PIN WITH A MICROMETER. RESULT WAS WITHIN THE SPECIFICATION AND AT THE LOWER LIMIT. NEXT WE CHECKED THE DIAMETER OF THE HOLE ON THE RELEVANT PART OF THE HANDLE. THE TEST PIN FELL THROUGH THE HOLE WITHOUT ANY RESISTANCE; THERE WAS CLEARLY A GAP BETWEEN THE PIN AND THE EDGE OF THE HOLE. IN THE NEXT STEP, WE CAREFULLY APPROACHED THE DRILL HOLE WITH LARGER AND LARGER TEST PINS SO AS NOT TO DAMAGE IT, UNTIL ONE PIN SLIPPED INTO THE HOLE WITHOUT ANY PLAY. 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 2(5) X PROBABILITY OF OCCURRENCE 1(5)) ACCORDING TO DIN EN ISO 14971 IS STILL ACCEPTABLE. EXPLANATION AND RATIONALE: THE HOLE IN A SINGLE PART OF THE HANDLE DID NOT MEET THE SPECIFICATION, SO THE CONNECTING PIN THAT WAS SUPPOSED TO JOIN THE PARTS SLIPPED OUT AND THE HANDLE FELL APART. CONCLUSION AND MEASURES / PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS, THE ROOT CAUSE IS MOST PROBABLY MANUFACTURING-RELATED. BASED UPON THE INVESTIGATION RESULTS, A CAPA IS NOT NECESSARY. THE RESPONSIBLE MANUFACTURING DEPARTMENT WAS INFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH PO381R - HANDLE WITH RATCHET FOR 3.5MM INSTR. ACCORDING TO THE COMPLAINANT, THE HANDLE DISASSEMBLED. THIS OCCURRED DURING NISSEN LAPAROSCOPIC FUNDOPLICATION SURGERY. THE PIN ON THE TOP OF THE HANDLE CAME OFF AND PARTS OF THE PRODUCT SCATTERED. AN ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. THE PROCEDURE WAS TEMPORARILY INTERRUPTED TO RETRIEVE THE PIECES. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). INVOLVED COMPONENTS: PO346R / JAW INS.CLINCHING GRSP FEN.3.5MM 290MM/ 400561172 / LOT UNKNOWN. PM986P/ INSULATED OUTER TUBE 3.5/3.5MM 290MM / 400561339 / LOT UNKNOWN.

    Description of Event or Problem · 0

    INVOLVED COMPONENTS: PO346R / JAW INS.CLINCHING GRSP FEN.3.5MM 290MM/ (B)(4). PO986R / INSULATED OUTER TUBE 3.5/3.5MM 290MM / (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877285 HANDLE WITH RATCHET FOR 3.5MM INSTR. HANDHELD PRODUCTS & LIGATION GEI AESCULAP AG PO381R

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention PM986P / INSULATED OUTER TUBE 3.5/3.5MM 290MM| PO346R / JAW INS.CLINCHING GRSP FEN.3.5MM 290MM| PO346R / JAW INS.CLINCHING GRSP FEN.3.5MM 290MM/ 4| PO986R / INSULATED OUTER TUBE 3.5/3.5MM 290MM / 40