BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESTIGE ATRA GRASPER DBL-ACT 5MM

    MDR report key: 12212180 · Received July 22, 2021

    Report

    Report Number
    2916714-2021-00145
    Event Type
    Malfunction
    Date Received
    July 22, 2021
    Report Date
    October 18, 2021
    Manufacturer
    AESCULAP INC
    Product Code
    NWV
    UDI-DI
    04046955083374
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: ORIGINALLY THE REPORTED COMPLAINT DESCRIPTION HAD BEEN UNCLEAR, WE ASSESED IT AS DISTAL TIP FAILURE. HOWEVER UPON RECEIPT IT WAS CLARIFIED AS PROXIMAL WELD FAILURE. A PRESTIGE GRASPER WAS RECEIVED FOR EVALUATION OF PROXIMAL WELD FAILURE WITH LOT NUMBER M47462; REPAIR INFORMATION WAS NOT AVAILABLE. THE INVESTIGATION WAS PERFORMED AT AESCULAP TEK PARK. VISUAL INSPECTION SUMMARY: NICKS IN THE COATING, SCRATCHES,SEPARATION AT PROXIMAL END. PHYSICAL AND FUNCTIONAL INSPECTION SUMMARY: ONE (1) UNIT WITH LOT # M47462 WAS RETURNED FOR EVALUATION. THERE WAS NO VISIBLE ETCHING BY INTERNAL ATS INDICATING THE INSTRUMENT HAD BEEN REPAIRED. UPON VISUAL OBSERVATION IT WAS CONFIRMED THAT THE DISTAL WELD WAS INTACT; HOWEVER, THE PROXIMAL WELD WAS SEPARATED. CONCLUSION: THE FAILURE MODE OF PROXIMAL WELD FAILURE WAS CONFIRMED. THIS EVENT LIKELY OCCURRED DUE TO INADEQUACIES IN THE DEFINED PRODUCTION PROCESS WHICH LIMITED THE DEVICE PERFORMANCE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS CONSIDERED TO BE MANUFACTURING RELATED. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS INITIATED DUE TO AN ADVERSE TREND OBSERVED FOR DEVICES EXHIBITING FAILURE AT THE THUMB-LOOP ASSEMBLY JOINT. THE SUPPLIER EVALUATED THE MALFUNCTION BY LOOKING AT DEVICES WITH A LOT NUMBER BEGINNING WITH "M." AS A RESULT OF THEIR FINDINGS, THE PUSH ROD FIXTURE WAS REDESIGNED TO INCREASE THE CLEARANCE, WHICH ENSURED THAT THE FIXTURE APPROPRIATELY STRESSED THE ENTIRETY OF THE SOLDERING JOINT. UPON IMPLEMENTING THE NEW FIXTURE, THE SUPPLIER TESTED RETURNED NONCONFORMING SAMPLES, AND VERIFIED THAT THE SOLDERING NO LONGER HUNG UP ON THE NEW FIXTURE, AS HAD BEEN OBSERVED ON THE PREVIOUS ONE. IN ADDITION TO THE REDESIGN OF THE SOLDERING FIXTURE, THE SUPPLIER REVIEWED THE WORK INSTRUCTION FOR THE TORCH SOLDERING OPERATION AND IDENTIFIED IMPROVEMENT OPPORTUNITIES. THE ORIGINAL WORK INSTRUCTION WAS USED TO BETTER DEFINE THE SOLDERING PROCESS WITH A MORE FOCUSED EMPHASIS ON THE FOLLOWING: EQUIPMENT STARTUP AND SHUTOFF OPERATIONS, CLEAR IMAGERY OF ACCEPTABLE SOLDERED SUBASSEMBLIES, AND CLARIFIED CLEANING OPERATIONS FOR COMPONENTS PRIOR TO SOLDERING. A SECOND DEDICATED WORK INSTRUCTION WAS IMPLEMENTED TO BETTER DEFINE THE ATTRIBUTE INSPECTION CRITERIA FOR THE BRAZING PROCESS USED FOR THE SOLDER BETWEEN THE THUMB LOOP AND ROTATOR BLOCK. IN ADDITION TO A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) BEING INITIATED, A CORRECTIVE ACTION/PREVENTIVE ACTION (CAPA) WAS OPENED BY AESCULAP INC. FOR FURTHER EVALUATION OF THE DESIGN TRANSFER OF THIS DEVICE.

    Additional Manufacturer Narrative · 1

    DURING A COMPREHENSIVE REVIEW OF THE REPORTED EVENT, IT WAS NOTED THAT THE FAILURE MODE OF THIS DEVICE WAS INITIALLY REPORTED AS THE SHAFT SEPARATED ITSELF/BROKE LOOSE AT THE JOINT / BRAZED AREA. AS PROXIMAL WELD FAILURE EVENTS WERE NOT ESCALATED TO REPORTABLE MALFUNCTIONS UNTIL (B)(6) 2019, THIS COMPLAINT WAS INITIALLY DEEMED A NON- REPORTABLE EVENT. REVIEW OF NEW RELEVANT INFORMATION, CONFIRMED THAT THE DEVICE HAD SEPARATED AT THE DISTAL WELD. AS THIS FAILURE MODE WAS ESCALATED TO A REPORTABLE MALFUNCTION IN (B)(6) 2017, THE INITIAL INFORMATION AND SUBSEQUENT INVESTIGATION RESULTS REQUIRED MDR REPORTING. THE DEVICE WAS RETURNED TO AESCULAP TECHNICAL SERVICE (ATS), AND FORWARDED TO AESCULAP RESEARCH AND DEVELOPMENT (TEK PARK) FOR EVALUATION. ALL DEVICE HISTORY RECORDS (DHR) ARE REVIEWED AND RELEASED ACCORDING TO DOCUMENTED PROCEDURES AND A DEVICE IS NOT RELEASED IF IT DOES NOT MEET REQUIREMENTS OR IS NONCONFORMING. ADDITIONALLY, HISTORICAL SCRAP RATES WERE REVIEWED WITH NO INCREASE OBSERVED IN SCRAP RELATED TO THE COMPLAINT ISSUE. THE SUPPLIER REVIEWED THE WORK INSTRUCTIONS (WI) FOR THE TUBE SUB ASSEMBLY TEST PROCEDURE WI, THE BRAZING PROCEDURE WI, AND THE BRAZED JOINT BUFFING WI AND IDENTIFIED IMPROVEMENT OPPORTUNITIES. WHILE THE TUBE SUBASSEMBLY JOINT IS 100% PERCENT TESTED WITH A TORSIONAL FORCE, THERE WAS NO REQUIREMENT FOR APPLYING A BENDING FORCE TO THE JOINT. THEREFORE, A MANUAL BEND TEST WAS ADDED TO THE WI. ADDITIONALLY, A REVIEW OF THE TORQUE TEST FIXTURE AND ACCOMPANYING WI, NOTED THE POTENTIAL FOR THE TUBE TO SLIP INSIDE THE COLLET DURING INSPECTIONS ALLOWING FOR A DEFECTIVE PART TO POTENTIALLY PASS THIS TEST. THE TUBE SUB ASSEMBLY TEST PROCEDURE WAS FURTHER UPDATED TO NOTE THIS POTENTIAL FAILURE MODE AND TO DEFINE THE PROCESS FOR CLEANING THE PARTS AND FIXTURE/COLLET WITH ALCOHOL PRIOR TO USE. A REVIEW OF THE BRAZING PROCEDURE WI REVEALED THAT THE GLASS TUBE WAS TOO SHORT TO EFFECTIVELY SEAL THE BRAZING AREA OFF FROM THE SURROUNDING ENVIRONMENT. WITHOUT A PROPER SEAL THE BRAZING AREA COULD HAVE INSUFFICIENT ARGON PRESENT TO FACILITATE EFFECTIVE BRAZING. THE BRAZING PROCEDURE WI WAS UPDATED TO INCLUDE A CHECK FOR THIS CONDITION PRIOR TO BRAZING. ADDITIONALLY, THE SUPPLIER UPDATED THE WI TO OPTIMIZE THE ORDER OF OPERATIONS OF WHEN FLUX IS APPLIED, THE SOLDERING RING IS ASSEMBLED, AND THE TUBE IS LOADED. THIS CHANGE ENSURED THAT FLUX WOULD BE PRESENT THROUGHOUT THE ENTIRE JOINT SPACE AND ALLOW FOR PROPER SOLDER TRAVEL. FURTHERMORE, A FUNCTIONAL REVIEW AND VISUAL EXAMINATION OF THE NEST, WHICH THE TUBE SUB ASSEMBLY SITS INTO, WAS PERFORMED. THIS REVIEW REVEALED THAT THE TWO ARGON ACCESS HOLES WERE CLOGGED. THEREFORE, THE ASSOCIATED PREVENTATIVE MAINTENANCE ACTIVITIES WERE UPDATED TO MONITOR THE ACCESS HOLES AND PREVENT A RECURRENCE OF BUILDUP. FINALLY, THE SUPPLIER UPDATED THE BRAZED JOINT BUFFING WI TO NOTE THE POTENTIAL FAILURE MODE OF EXCESSIVE BUFFING, WHICH COULD REMOVE TOO MUCH MATERIAL AND WEAKEN THE JOINT. THE INVESTIGATION INTO THE CAUSE OF THE REPORTED PROBLEM WAS ABLE TO CONFIRM THE FAILURE MODE OF A DISTAL BRAZE FAILURE/BREAKAGE. THIS EVENT LIKELY OCCURRED DUE TO INADEQUACIES IN THE DEFINED PRODUCTION PROCESS WHICH LIMITED THE DEVICE PERFORMANCE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS CONSIDERED TO BE MANUFACTURING RELATED, FORCEFUL USE AND WEAR AND TEAR. AESCULAP INC. OPENED A CORRECTIVE ACTION/PREVENTIVE ACTION (CAPA) FOR FURTHER EVALUATION OF THE DESIGN TRANSFER OF THIS DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A PRESTIGE GRASPER. THE SHAFT BROKE/CAME APART AT THE WORKING END AREA. SHAFT SEPARATED AT THE JOINT/BRAZING AREA.. THERE WAS NO PATIENT INVOLVEMENT NOR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1106619 PRESTIGE ATRA GRASPER DBL-ACT 5MM REUSABLE INSTRUMENTS NWV AESCULAP INC 8360-10 M47462 04046955083374

    Patients

    Seq Age Sex Outcome Treatment
    1