BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL

    MDR report key: 1888155 · Received November 2, 2010

    Report

    Report Number
    3005075853-2010-06252
    Event Type
    Malfunction
    Date Received
    November 2, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 14, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K032676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    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

    NOTE: THIS MANUFACTURER REPORT PERTAINS TO ONE OF THREE CAPIO OPEN ACCESS SUTURE CAPTURING DEVICES USED DURING THE SAME PROCEDURE. ASSOCIATED MANUFACTURER REPORT NUMBERS 3005099803-2010-05239 AND 3005099803-2010-05240 PERTAIN TO THE OTHER TWO DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A SACROSPINOUS LIGAMENT FIXATION PROCEDURE USING A CAPIO OPEN ACCESS SUTURE CAPTURING DEVICE, THE CAPIO CARRIER AND THE NEEDLES OF TWO 48" POLYPROPYLENE CAPIO SUTURES (MANUFACTURED BY TELEFLEX MEDICAL INC, DISTRIBUTED BY BOSTON SCIENTIFIC CORP.) DETACHED DURING SUTURING. "SEVERAL" ATTEMPTS TO SUTURE WERE MADE "BECAUSE NEEDLE WASN'T RETRIEVED AUTOMATICALLY BY CAPIO [DEVICE]." IT IS UNKNOWN IF THE CAPIO CARRIER AND NEEDLES DETACHED INSIDE OR OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THIS CAPIO OPEN ACCESS SUTURE CAPTURING DEVICE WITH "NO ACTION TAKEN BY THE PHYSICIAN TO RESOLVE THE EVENT." THERE WERE NO COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY "STABLE" POST-PROCEDURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SLEEVE PROCEDURE, SINCE THE BEGINNING OF THE PROCEDURE, IT LOST PNEUMO CONSTANTLY. DUE TO THIS PROBLEM, THEY HAD TO STOP THE PROCEDURE VERY OFTEN. THEY DECIDED NOT TO OPEN. UNKNOWN HOW CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH** XCEL LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1