BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHAFT COMPL.D:10MM L:370MM

    MDR report key: 6042116 · Received October 19, 2016

    Report

    Report Number
    2916714-2016-00869
    Event Type
    Malfunction
    Date Received
    October 19, 2016
    Date of Event
    September 26, 2016
    Report Date
    April 12, 2017
    Manufacturer
    AESCULAP AG
    Product Code
    OCW
    PMA / PMN Number
    K962493
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4) (MANUFACTURER). EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: FRANCE. DURING USE OF THE LIGATION CLIPS WITH APPLIER IN A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CARTRIDGE DETACHED FROM THE DEVICE AND FELL INTO THE PATIENT DURING THE APPLICATION OF THE 4TH CLIP. THE DEVICE WAS LOCATED IN THE PERITONUEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. COMPONENTS IN USE LISTED AS CONCOMITANT DEVICES ARE: PL536R / SHAFT COMPL.D:10MM L:370MM. PL520R / CHALLENGER TI-P HANDLE. PL579T / GER TI-P ML-LIGAT.CLIPS 12 CARTR.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE INVESTIGATION WAS CARRIED OUT BY THE QUALITY ASSURANCE DEPARTMENT. HANDLES: INITIAL WEIGHT END WEIGHT LOSS OF WEIGHT NUMBER OF ACTIVATIONS #1 N/A N/A N/A N/A BROKEN #2 216,108 216,106 0,002 31 OK HANDLE #1 IS BROKEN, A FUNCTIONAL TEST COULD NOT BE CARRIED OUT. HANDLE #2 IS ACCORDING TO THE SPECIFICATIONS. SHAFTS: #1 TARGET ACTUAL *03* 67,80 -0,1 MM 6,77 MM OK *04* 3,85 +0,2 MM 3,90 MM FAULTY * *05* 7,00 -0,1-0,3 MM 6,75 MM OK *06* 6,60 +0,1 MM 6,60 MM OK #2 TARGET ACTUAL *03* 67,80 -0,1 MM 67,75 MM OK *04* 3,85 +0,2 MM 3,99 MM OK *05* 7,00 -0,1-0,3 MM 6,97 MM OK *06* 6,60 +0,1 MM 6,60 MM OK SHAFT #1: * THE MECHANIC IS DAMAGED, A TILTING OF THE MECHANIC IS POSSIBLE. SHAFT #2: THE WELDING SEAM OF THE RIGHT JAW PART IS BROKEN OFF. BATCH HISTORY REVIEW: THE PRODUCTS DOES NOT REQUIRE BATCH MANAGEMENT; A REVIEW OF THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS IS NOT POSSIBLE. CONCLUSION AND ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE AS WELL AS A RESULT OF OUR INVESTIGATION THE ROOT CAUSE OF THE FAILURE IS MOST PROBABLY A MANUFACTURING ERROR. RATIONAL: THE WELDING SEAM IS MADE BY HAND BUT NO OTHER SIMILAR COMPLAINT IS NOTED IN SAP. THUS WE EXCLUDE A SYSTEMATICAL ERROR. IT MAY NOT BE EXCLUDED THAT THE BROKEN WELDING SEAM CAUSED THE DETACHING OF THE MAGAZINE. THE ERROR OF THE BROKEN HANDLE IS MOST LIKELY CAUSED BY REPROCESSING WITHOUT REMOVING THE GAS-CYLINDER OUT OF THE HANDLE. THUS THE GAS-CYLINDER EXPLODED CAUSED BY THE INCREASE OF THE TEMPERATURE. CORRECTIVE ACTION: ACCORDING TO SOP SA-DE13-M-4-2-01-010 A CAPA IS NOT NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690573 SHAFT COMPL.D:10MM L:370MM ENDOSCOPY OCW AESCULAP AG PL536R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other PL520R / CHALLENGER TI-P HANDLE| PL536R / SHAFT COMPL.D:10MM L:370MM| PL579T / GER TI-P ML-LIGAT.CLIPS 12 CARTR.| PL520R / CHALLENGER TI-P HANDLE| PL536R / SHAFT COMPL.D:10MM L:370MM| PL579T / GER TI-P ML-LIGAT.CLIPS 12 CARTR.