BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEALING CAP

    MDR report key: 1021572 · Received March 27, 2008

    Report

    Report Number
    1418479-2008-00008
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Date of Event
    March 3, 2008
    Report Date
    March 27, 2008
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: 89.01RE SEALING CAP. USER FACILITY COULD NOT IDENTIFY THE ENDOSCOPE THAT WAS USED WITH THE SEALING CAP. THE SEALING CAP IS MANUFACTURED FROM A SILICONE RUBBER THAT IS RED IN COLOR. VISUAL INSPECTION OF THE SEALING CAP SHOWED THE CIRCULAR PIECE FROM THE TOP PART MISSING. THE 6.7MM CIRCULAR PIECE WAS JAGGED IN APPEARANCE AROUND THE EDGE. THE INSERT CAPACITY OF THIS SEALING CAP IS 2MM TO 3 MM. RICHARD WOLF SEALING CAP CHART INSTRUCTIONS SPECIFIES A 5.5 MM OR LESS FITTING FOR THIS SEALING CAP. CAUSE: THE OTHER INSTRUMENT (ENDOSCOPE) PORT THAT WAS USED WITH THE SEALING CAP WAS LARGER IN DIAMETER THAN 2MM-3MM INSERT CAPACITY.

    Description of Event or Problem · 1

    DURING A DIAGNOSTIC LAPAROSCOPIC PROCEDURE, THE CENTER PART OF THE SEALING CAP FELL THROUGH THE SCOPE INTO THE PT'S ABDOMINAL CAVITY. THE SEALING CAP CENTER PART WAS RETRIEVED WITH A GRASPER FORCEPS. THERE WAS NO DELAY IN THE SURGERY. THERE WAS NO PT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEALING CAP SEALING CAP GCJ RICHARD WOLF MEDICAL INSTRUMENTS 89.01RE

    Patients

    Seq Age Sex Outcome Treatment
    1