BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISP.TROCAR THRD.W.DILATING PIN 12/110MM

    MDR report key: 8772217 · Received July 9, 2019

    Report

    Report Number
    9610612-2019-00450
    Event Type
    Malfunction
    Date Received
    July 9, 2019
    Date of Event
    June 13, 2019
    Report Date
    August 30, 2019
    Manufacturer
    AESCULAP AG
    Product Code
    GCJ
    PMA / PMN Number
    K101937
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION WE MADE A VISUAL INSPECTION OF THE SEALING UNIT. HERE WE FOUND A BROKEN OFF FRAGMENT AND UNKNOWN IMPURITIES. ADDITIONAL WE MADE AN OPTICAL INSPECTION OF THE LOCKING RING EK002241 AND CROSS SLOT VALVE EK002251. NO VISIBLE DAMAGE BUT UNKNOWN IMPURITIES WERE ALSO DETECTED. NEXT WE MADE A VISUAL INSPECTION OF THE SHELL EK002240 WITH UNIVERSAL CONVERTER K002250 AND BLINDING-PROTECTOR EK002252. HER WE DISCOVERED VISIBLE DAMAGE AND AN UNKNOWN PRODUCT. FURTHERMORE WE MADE A VISUAL INSPECTION OF THE EK02250 AND UNIVERSAL CONVERTER. HER WE FOUND VISIBLE DAMAGE AND THE UNKNOWN PRODUCT. WE ALSO MADE AN OPTICAL INSPECTION OF THE BLINDING-PROTECTOR EK002252. HERE WE GROUND UNKNOWN IMPURITIES. BATCH HISTORY REVIEW THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR THE LOT NUMBER (52502762) AND FOUND TO BE ACCORDING TO THE SPECIFICATION, VALID AT THE TIME OF PRODUCTION. NO SIMILAR INCIDENTS HAVE BEEN FILED WITH PRODUCTS FROM THIS BATCH. CONCLUSION AND ROOT CAUSE THE ROOT CAUSE OF THE PROBLEM IS MOST PROBABLY USAGE RELATED. RATIONALE ACCORDING TO THE QUALITY STANDARD AND DHR FILES A MATERIAL DEFECT AND PRODUCTION ERROR CAN B EXCLUDED. INVESTIGATIONS LEAD TO THE ASSUMPTION THAT THE VISIBLE DAMAGED UNIVERSAL CONVERTER EK002250 WAS CAUSED BY AN IMPROPER HANDLING. IT APPEARS THAT THE UNKNOWN PRODUCT IS A THIRD-PARTY PRODUCT. DUE TO THE THIRD- PARTY PRODUCTION THERE IS THE POSSIBILITY FOR A MALFUNCTION DUE TO AN INCOMPATIBLE INSTRUMENT. BY INSERT THE INSTRUMENT THE UNIVERSAL CONVERTER COULD HAS BEEN DAMAGED. PER THE IFU CAUTION MUST BE OBSERVED AS MALFUNCTION CAN OCCUR DUE TO INCOMPATIBLE INSTRUMENTS. NO CAPA NEEDED.

    Additional Manufacturer Narrative · 1

    WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE VALVE ON THE SEAL WAS SHREDDED. THE REPORTER INDICATED THAT DURING A SURGICAL PROCEDURE IT WAS NOTICED THAT THE VALVE ON THE SEAL WAS SHREDDED AND EVENTUALLY FELL INTO PATIENT'S BODY. THE SURGEON REMOVED THE FRAGMENT FROM THE PATIENT'S BODY. PER THE REPORTER, ALL FRAGMENTS WERE REMOVED. IT WAS ALSO REPORTED THAT THE PHYSICIAN MENTIONED THAT WHEN HE USED DS CLIP, VALVES MOST LIKELY DAMAGED AND CHANGED EK002SU A FEW TIMES. ALSO, AIR TIGHTNESS GOT WORSE AFTER DS CLIP WAS USED. THE DS APPLIER'S JAWS ARE OPEN WHEN IT IS INSERTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER, AS OF THIS REPORT HAS NOT YET BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565071 DISP.TROCAR THRD.W.DILATING PIN 12/110MM ACCESS / TROCARS GCJ AESCULAP AG EK236SU 52502762

    Patients

    Seq Age Sex Outcome Treatment
    1