BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE ILS CURVED CIR STAPL

    MDR report key: 2212478 · Received August 16, 2011

    Report

    Report Number
    3005075853-2011-03313
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    July 4, 2011
    Report Date
    August 3, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2011: NOTE THAT THE PROCEDURE WAS CARRIED OUT ON (B)(6) AND THE PATIENT WAS TAKEN BACK TO THEATRE ON (B)(6). PATIENT IS MALE. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2011: NO, IT WAS NOT THE BLUE ANCILLARY TROCAR. IT WAS THE PART OF THE INTERLAMINAL STAPLER THAT YOU REMOVE AND PUT ON THE PROXIMAL PORTION OF THE BOWEL AND THEN RECONNECT TO THE DISTAL PART OF THE INSTRUMENT TO PERFORM THE ANASTAMOSIS. AGAIN, IT WAS NOT THE ANCILLARY TROCAR AS THE ANCILLARY TROCAR WAS NOT USED AS THEY USED A PER-STRING SUTCHURE TECHNIQUE. THE SURGEON ATTACHED THE TROCAR AND THE DISTAL PORTION OF THE STAPLER LAPAROSCOPICALLY AND AN AUDIBLE CLICK WAS HEARD AND THE SURGEON PULLED ON THE TROCAR TO ENSURE THAT IT WAS ATTACHED PROPERLY. IF THE TROCAR WAS NOT ATTACHED PROPERLY THE STAPLES WOULD NOT HAVE FORMED PROPERLY AND THEY DID. BUTTRESSING MATERIAL WAS NOT USED. THE SURGEONS EXPERIENCED A CRUNCH AND AN AUDIBLE SOUND TO CONFIRM THAT THE STAPLE HAD FIRED PROPERLY. THERE WAS NOTHING UNEXPECTED WITH THE FIRING OF THE DEVICE. THE ISSUES THAT CAUSED THE HEAD OF THE INSTRUMENT/TROCAR TO UNATTACH ITSELF FROM THE INSTRUMENT WAS THAT THE REGISTRAR HAD OPENED THE DEVICE ALL THE WAY INSTEAD OF THE RECOMMENDED ½ TO ¾ TURNS. ALL DONUTS WERE CORRECT AND A LEAK TEST WAS PERFORMED CONFORMING A GOOD ANASTAMOSIS. THE REGISTRAR AND NOT THE SURGEON FIRED THE DEVICE. IT IS UNKNOWN IF HE WAS EXPERIENCED OR NOT. THE PATIENT WAS STILL IN HOSPITAL WHEN THE INITIAL SYMPTOMS OF PAIN ON TRYING TO PASS FAECES WERE EXPERIENCED. THE PATIENT WENT HOME THE FOLLOWING DAY AFTER THE PATIENT WENT BACK TO THEATRE FOR REMOVAL OF THE TROCAR AND THE TROCAR WAS INTACT. PATIENT IS DOING WELL AD DID NOT NEED TO COME BACK TO HOSPITAL.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCES. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE, IT WAS NOT NOTICED THAT THE TROCAR WAS NOT ATTACHED TO THE DEVICE WHEN IT WAS REMOVED FROM THE PATIENT. THREE DAYS LATER, THE PATIENT COMPLAINED OF PAIN ON TRYING TO PASS FECES. UPON EXAMINATION, THE TROCAR TIP WAS PROTRUDING TO THE PATIENT'S ANUS; THEREFORE THE PATIENT HAD TO GO BACK TO THEATRE FOR MANUAL REMOVAL OF TROCAR UNDER ANESTHETIC.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE ILS CURVED CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R