BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE ILS INTRALUMINAL STAPLER

    MDR report key: 115478 · Received August 21, 1997

    Report

    Report Number
    1527736-1997-02115
    Event Type
    Malfunction
    Date Received
    August 21, 1997
    Report Date
    July 25, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY EXPERIENCED AN EVENT WITH PROXIMATE* I L S INTRALUMINAL STAPLER ON WHILE PERFORMING A ESOPHAGOGASTRECTOMY. THE PRODUCT COMPLAINT TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY # 974582. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW: VISUAL INSPECTIONS & RESULTS: B/A WASHER PRESENT/CONDITION, PRESENT/UNCUT WITH; DAMAGED ANVIL / ANVIL SHROUD, YES/MISSING TROCAR; DAMAGED GUIDE FACE, NO; DAMAGED KNIFE, NO ; DAMAGED STAPLE POCKETS, NO ; DAMAGED TROCAR, NO ; MISSING PARTS, TROCAR CLIP ; SERIAL NUMBER, 188 ; STAPLES PRESENT/LOCATION, NO AND TISSUE PRESENT/DESCRIBE, NO. ANALYSIS CONCLUSION: BASED ON INFO RECEIVED AND THE VISUAL INSPECTION, IT WAS CONCLUDED THAT THE INSTRUMENT WAS MISASSEMBLED DURING THE MFG PROCESS. UPON RECIEPT OF THE INSTRUMENT, IT WAS VERIFIED THAT THE TROCAR CLIP (LOCKING SPRING) WAS MISSSING FROM THE ANVIL. IT COULD NOT BE DETERMINED AS TO HOW OR WHY THIS WAS NOT DISCOVERED DURING THE ASSEMBLY PROCESS. EMPLOYEE AWARENESS SESSIONS WILL BE HELD AS A RESULT OF THIS INQUIRY. MFG AND ENGINEERING HAVE BEEN NOTIFED OF THE REPORTED INCIDENT. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT IS REPORTED IN ORDER TO CONTINUOUSLY IMPROVE THE PRODUCTS.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING THE PROCEDURE ONE OF THE-IN THE ANVIL HEAD WAS BROKEN AND THE ANVIL COULD NOT BE LOCKED SECURELY ON THE TROCAR. WHEN FIRING, THE ANVIL MOVED FORWARD, FORMING ONLY HALFWAY OPENED STAPLES. THE SURGEON REMOVED THE MALFORMED STAPLES. A NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE ILS INTRALUMINAL STAPLER CIRCULAR STAPLERS GAG ETHICON ENDO-SURGERY, INC. NA DM11CN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other