BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOSCOPIC MULTIFEED STAPLER - 360? ROTATION 20 TITANIUM STAPLES

    MDR report key: 1905302 · Received November 23, 2010

    Report

    Report Number
    3005075853-2010-06641
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 28, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K913469
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). DAMAGED LIFTER. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WAS THE DEVICE REPROCESSED? EMS WAS NEW STAPLER I BROUGHT FROM STOCK OF DISTRIBUTOR. WERE ANY OTHER DIFFICULTIES NOTED WITH THE DEVICE PRIOR TO THE INCIDENT? DEVICE IS NEW (THE ONLY PROBLEM THAT IT HAD THREE CLIPS INSIDE INSTEAD OF 20 CLIPS& WE COULDN'T KNOW THAT UNLESS WE USE DEVICE (NO COUNT INDICATOR). WHAT WAS THE REASON FOR NOT COMPLETING THE OTHER SIDE? WAS THERE NOT ANOTHER DEVICE AVAILABLE? WE ALWAYS USE ONE DEVICE PER PATIENT (10-15) CLIPS IN BOTH SIDES. THERE IS NO STOCK IN THE HOSPITAL .THE PATIENT BUY DEVICE FROM DISTRIBUTOR DIRECTLY. HAS THE SECOND PROCEDURE TAKEN PLACE TO FINISH THE OTHER SIDE? BECAUSE THE PATIENT INSIST TO DO THE PROCEDURE TOTALLY BY LAPAROSCOPY. DOCTOR (B)(6) DID ONLY ONE SIDE & POSTPONED OTHER SIDE LATER BECAUSE THE HOSPITAL DIDN'T KEEP STOCK. DID THE PATIENT PRESENT WITH AN INTESTINAL OBSTRUCTION? IF SO, PLEASE EXPLAIN THE STEPS TAKEN TO CORRECT THE ISSUE? UNKNOWN. HAS THE PATIENT HAD A FULL RECOVERY? UNKNOWN. PATIENT'S SEX, AGE, WEIGHT? PRE-EXISTING CONDITIONS? THE PATIENT IS MALE IN (B)(6) WITH GOOD HEALTH & (B)(6). THE ANALYSIS RESULTS SHOWED THAT ONE DEVICE WAS RECEIVED NON-FUNCTIONAL AS THE LIFTER WAS NOTED TO BE BROKEN. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITIONS OF THE INTERNAL COMPONENTS AND THE LIFTER WAS NOTED TO BE BROKEN. IT IS POSSIBLE THAT THE TIP OF THE DEVICE WAS JAMMED AGAINST A HARD OBJECT, PREVENTING THE LIFTER FROM MOVING TO IT IS POSSIBLE THAT THE TIP OF THE DEVICE WAS CONSTRAINED DURING THE PROCEDURE IN A MANNER AS TO PROHIBIT THE NATURAL MOVEMENT OF THE LIFTER. ATTEMPTING TO FIRE THE DEVICE IN REPEATEDLY ATTEMPTS WILL CAUSE THE STAPLES TO JAM AND ULTIMATELY ENOUGH PRESSURE WILL BUILD IN THE NOSE TO OPEN IT. IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS; (B)(4). EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THAT THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BILATERAL INGUINAL HERNIA PROCEDURE, WHEN THE SURGEON FIRED THE INSTRUMENT, THERE WERE ONLY THREE CLIPS INSIDE AND HE CLOSED THAT SIDE WITH SUTURES. HE DIDN'T DO THE OTHER SIDE BECAUSE THERE WERE NO MORE CLIPS IN EMS. REDO PROCEDURE FOR THE OTHER SIDE AND THE PATIENT MAY HAVE INTESTINAL OBSTRUCTION, EXPOSURE OF MESH. OPERATED ONLY ONE SIDE OF THE HERNIA AND POSTPONED THE OTHER SIDE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSCOPIC MULTIFEED STAPLER - 360? ROTATION 20 TITANIUM STAPLES LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. G4TH3W

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization