BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 2033238 · Received March 30, 2011

    Report

    Report Number
    3005075853-2011-01259
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    February 17, 2011
    Report Date
    March 7, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COMPLAINT STATED THAT THERE WAS A CUT ON THE TYVEK. THE CARTON WAS NOT RETURNED AND THEREFORE IT COULD NOT BE EXAMINED FOR DAMAGE. THE SEALED PACKAGE WAS VISUALLY EXAMINED. THE PACKAGE WAS CRUMPLED AND SHOWED SOME EVIDENCE OF ROUGH HANDLING ON ENTIRE PACKAGE. A HOLE WAS PRESENT ON TYVEK NEAR CORNER OF PACKAGE AND ALMOST OVER THE TOP CORNER OF THE INSTRUMENT. THE HOLE DOES NOT ALIGN WITH THE DEVICE. THE HOLE WAS FORMED FROM THE OUTSIDE IN AND IS V-SHAPED. THIS WAS CONFIRMED VISUALLY THROUGH MICROSCOPE. IT APPEARS THAT THE PACKAGE WAS STRUCK FROM THE OUTSIDE CAUSING PUNCTURE HOLE THROUGH THE TYVEK. BATCH G4U93F HAD NO NONCONFORMANCE, DEFECTS OR REWORK DURING ITS MANUFACTURE. EQUIPMENT RECORDS WERE CHECKED FOR DAY OF PACKAGE MANUFACTURE WITH NO RELEVANT ISSUES NOTED. PACKAGING PROCESS WAS REVIEWED AND IT WAS CONCLUDED THAT NOTHING ON THE PACKAGING MACHINE OR IN THE MATERIAL/PRODUCT HANDLING PROCESS COULD BE ESTABLISHED TO HAVE CAUSED THIS ISSUE. CAUSE AND TIME OF THE DAMAGE TO THE PACKAGE COULD NOT BE DETERMINED, BUT MOST LIKELY OCCURRED OUTSIDE OF EES PACKAGING, AS PACKAGING PROCESS AT SORT FUNCTION HAS 100% VISUAL INSPECTION OF EACH PACKAGE.

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A COLON PROCEDURE, THERE WAS A HOLE IN THE TYVEK. WHEN THE NURSE WANTED TO OPEN THE PRIMARY BLISTER, SHE NOTICED THAT THERE WAS AS A CUT (2/3 MM LENGTH) ON THE OPPOSITE CORNER OF THE PAPER PART OF THE TYVEK. NO INFORMATION AVAILABLE ABOUT THE BOX IF THERE IS ANY DAMAGE NOTICED OR NOT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA G4U93F

    Patients

    Seq Age Sex Outcome Treatment
    1