BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH** ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER

    MDR report key: 4921473 · Received July 17, 2015

    Report

    Report Number
    3005075853-2015-04362
    Event Type
    Injury
    Date Received
    July 17, 2015
    Date of Event
    June 23, 2015
    Report Date
    June 23, 2015
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    KOG
    PMA / PMN Number
    K940967
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF FURTHER DETAILS ARE RECEIVED AND/OR DEVICE IS RECEIVED AND ANALYZED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION RECEIVED: THE ER PHYSICIAN'S NAME IS NOT KNOWN AT THIS TIME. THE ER PHYSICIAN STATED TO THE NURSE THAT THE PATIENT HAS A SMALL BOWEL OBSTRUCTION DUE TO "SLIGHT MOTILITY OF THE STOMACH" NOT RELATED TO THE ANVIL THAT WAS EXPELLED. THE PATIENT IS AWARE OF THE ANVIL THAT HE EXPELLED. THE NURSE STATED THAT THE "LAST TIME SHE SAW THE EXPELLED ANVIL, IT WAS IN A SPECIMEN CUP IN THE ER". IT WAS REPORTED THAT THE REP SPOKE WITH THE SURGEON AND OR SUPERVISOR AND WANTED TO UPDATE DETAILS. THE CORRECT DEVICE CODE IS (B)(4). THE PATIENT UNDERWENT A COLOSTOMY REVERSAL BEHIND PERFORMED BY SURGEON ON (B)(6) 2015 USING A PORTION OF THE SIGMOID COLON THAT HAD BEEN LEFT. DURING THE PROCEDURE, THE SURGEON FIRED THE CIRCULAR STAPLER. THE ANASTOMOSES WAS CHECKED BY PROCTOSCOPY AND LOOKED FINE. NO LEAKS WERE DETECTED. THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. THE PATIENT WAS RELEASED POST OPERATIVELY WITHOUT INCIDENT. THE PATIENT RETURNED TO THE EMERGENCY DEPARTMENT ON (B)(6) 2015 AND HAD A BOWEL MOVEMENT AND PASSED THE ANVIL IN HER STOOL. AT THIS TIME THE PATIENT WAS DIAGNOSED WITH A SMALL BOWEL OBSTRUCTION. THE SURGEON REPORTS THAT THE SMALL BOWEL OBSTRUCTION IS UNRELATED TO COLOSTOMY REVERSAL PROCEDURE. THERE HAVE BEEN NO ADDITIONAL PATIENT CONSEQUENCES AND THE PATIENT HAS BEEN RELEASED. WAS THERE ANY ISSUE NOTED WITH DEVICE PERFORMANCE DURING THE INITIAL PROCEDURE? NOTHING WAS REPORTED BY THE SURGEON UPON FOLLOW UP INTERVIEW. WHAT WAS THE INDICATION GIVEN FROM THE DEVICE THAT THE ANVIL WAS PROPERLY ATTACHED? THE SURGEON EXPLAINED THERE WAS NO INDICATION THAT THE ANVIL WAS NOT PROPERLY ATTACHED. WAS THE FORCE TO FIRE HIGHER OR LOWER THAN EXPECTED? THE FORCE TO FIRE WAS NORMAL HOW MANY COUNTER-CLOCKWISE REVOLUTIONS WERE USED TO OPEN DEVICE? SURGEON STATED HE OPENED IT HALF AND 3/4. DID THE SURGEON HAVE ANY DIFFICULTY REMOVING THE DEVICE? NO DIFFICULTY WERE THERE ANY ISSUES NOTED WITH STAPLE FORMATION? NONE. A LEAK TEST WAS DONE UNDER PROCTOSCOPE AND EVERYTHING LOOKED NORMAL DID THE OR TEAM INSPECT THE DONUTS IN THE INITIAL PROCEDURE? WHAT DID THEY LOOK LIKE? THE SURGEON INSPECTED THE DONUTS. THEY LOOKED NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST-OP OF A LAPAROSCOPIC COLOSTOMY REVERSAL PROCEDURE, THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) WITH PAIN. DURING THE ER VISIT, THE PATIENT PROCEEDED TO HAVE A BOWEL MOVEMENT IN WHICH HE PASSED A BLUE ANVIL FROM AN INTRALUMINAL STAPLER. THE ER PHYSICIAN HAS ADMITTED THE PATIENT FOR A SMALL BOWEL OBSTRUCTION. THE PATIENT UNDERWENT THE LAPAROSCOPIC COLOSTOMY REVERSAL PROCEDURE ON (B)(6) 2015. THERE WERE NO PATIENT CONSEQUENCES NOTED AFTER THE COLOSTOMY REVERSAL PROCEDURE. IT IS UNKNOWN IF THE ANVIL WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466091 ENDOPATH** ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER ENDOSCOPE AND/OR ACCESSORIES KOG ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1