BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESTIGE ATRA GRASPER DBL-ACT 5MM

    MDR report key: 9638943 · Received January 28, 2020

    Report

    Report Number
    2916714-2020-00035
    Event Type
    Injury
    Date Received
    January 28, 2020
    Date of Event
    January 13, 2020
    Report Date
    April 28, 2021
    Manufacturer
    AESCULAP INC
    Product Code
    NWV
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION: IT WAS REPORTED THAT A PRESTIGE GRASPER WAS RETURNED TO AESCULAP TECHNICAL SERVICES (ATS) REPAIR. INCLUDED WITH THE DEVICE AND ORDER, WAS A NOTE THAT STATED, "DURING SURGERY, TWO PIECES OF THE TIP OF THE GRASPER BROKE OFF IN THE PATIENT. THE TWO PIECES HAVE NOT BEEN CLEANED. THE GRASPER HAS BEEN CLEANED. " AN INITIAL REVIEW OF THE DEVICE BY ATS SHOWED THAT A THIRD PIECE WAS MISSING. THE THIRD PIECE WAS REPORTED TO BE A "SPACER" DESCRIBED AS A SMALL (2-3MM) PLASTIC-LIKE PORTION OF THE DEVICE. IT WAS ADDITIONALLY REPORTED THAT ALL PACKAGING MATERIALS AND ANY RETURNED FRAGMENTS WERE INADVERTENTLY DISCARDED BY WAREHOUSE STAFF DURING RECEIPT, PROCESSING AND HANDLING OF THE DEVICE. THE COMPLAINED DEVICE WAS REPORTED TO BE A REFURBISHED PRESTIGE GRASPER (TS0153) AND MOST LIKELY DOES NOT CONTAIN ANY OF ITS ORIGINAL PARTS (THE LAST REPAIR DATE WAS OCTOBER 2019). FURTHER INVESTIGATION BY AESCULAP INC.: SECTION A: VISUAL INSPECTION [ X ] NICKS, SCRATCHES OR DEFECTS [ X ] OTHER VISIBLE DEFECTS VISUAL INSPECTION SUMMARY: ONE (1) 8360-10 UNIT WITH LOT NUMBER L795 WAS RETURNED FOR INVESTIGATION. THERE WAS ETCHING INDICATING THE UNITS WERE REPAIRED BY AESCULAP TECHNICAL SERVICE IN OCTOBER 2019. IT WAS CONFIRMED THAT THE DELRIN SPACER WAS MISSING FROM THE DEVICE, CONFIRMING THE REPORTED FAILURE. SECTION B PHYSICAL INSPECTION SUMMARY: PHYSICAL EVALUATION IS NOT WARRANTED AS THE REPORTED DEFECT IS VISUALLY CONFIRMED. THE ROOT CAUSE IS EITHER IMPOROPER REPAIR OR MANUFACTURING ERROR. SECTION C: CONCLUSION [X ] CONFIRMED ROOT CAUSE (AESCULAP) - ALTHOUGH THIS REPORTED INCIDENT WAS REPORTED AFTER INITIATION OF AESCULAP CAPA, IT IS NOTED THAT CAPA WAS ISSUED IN DECEMBER 2019, TO EVALUATE THE DESIGN AND PRODUCTION ACTIVITIES THAT WERE PERFORMED AND DOCUMENTED FOR THE PRESTIGE GRASPER PRODUCT LINE (PN'S: 8360-10, 8360-00, 8361-10, 8361-00.) THE ACTIVITIES INCLUDED THE DOCUMENTATION OF MANUFACTURING PROCESSES AND CONTROLS AND DESIGN TRANSFER FROM PRIOR MANUFACTURER, TO CURRENT CONTRACT MANUFACTURER.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE PRESTIGE GRASPER. DURING SURGERY, 2-3 PIECES OF THE TIP OF THE GRASPER BROKE OFF INTO THE PATIENT. AT LEAST 2 PIECES WERE RETRIEVED WITH ANOTHER LAPAROSCOPIC GRASPER. THE THIRD PIECE, A SPACER, WOULD BE 2-3 MM AND MAY ALSO HAVE FALLEN THROUGH THE TROCAR; IT IS NON-METALLIC PLASTIC MATERIAL. NO X-RAYS WERE TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102944 PRESTIGE ATRA GRASPER DBL-ACT 5MM REUSABLE INSTRUMENTS NWV AESCULAP INC 8360-10 L795

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention