BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO LINEAR CUTTERS

    MDR report key: 6176618 · Received December 15, 2016

    Report

    Report Number
    3005075853-2016-07053
    Event Type
    Injury
    Date Received
    December 15, 2016
    Date of Event
    November 17, 2016
    Report Date
    November 28, 2016
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) DATE SENT: 1/12/2017. ADDITIONAL INFORMATION REQUESTED AND RECEIVED: WHAT WERE THE INDICATIONS FOR SURGERY? - BARIATRIC SURGERY (GASTROPLASTY) TECHNIQUE BYPASS. HOW WAS THE DEFECT/FISTULA CORRECTED IN PRIMARY PROCEDURE? - THE PROBLEM WAS CORRECTED WITH THE USE OF SUTURE WIRE, WHOLE GASTRO ANASTOMOSIS. HOW LONG POST-OP DID ISSUE OCCUR? - 04 DAYS AFTER PROCEDURE WHAT COLOR CARTRIDGES WERE USED? - BLUE CARTRIDGE 6R45B 05 UNITS - WHITE CARTRIDGE TR45W 02 UNITS PLEASE DESCRIBE STAPLE FORM. WAS ENTIRE STAPLE LINE MALFORMED? - THERE WAS A BAD FORMATION ON 01 CLAMP ACROSS THE LINE. IS IT ROUTINE FOR SURGEON TO PLACE DRAIN FOR THIS SURGICAL PROCEDURE? - TEAM USES OUR DRAIN IN ALL PROCEDURE CODE 2228 (15 FR) AND 2160 (RESERVOIR). WHAT IS THE CURRENT PATIENT STATUS? - PATIENT WAS DISCHARGED, AFTER RETURN OF THE HEAD OF THE TEAM WILL HAVE MORE DETAILED INFORMATION OF THE CURRENT STATE OF THE PATIENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A GASTROPLASTY BYPASS PROCEDURE, THERE WAS A POOR FORMATION IN THE STAPLE LINE IN A STAPLE (FISTULA), WHICH REQUIRED FURTHER INTERVENTION. CORRECT SURGICAL PROTOCOL, BUT AFTER DISCHARGE OF PATIENT, THE PATIENT PRESENTED PAIN AND A LEAK WAS DETECTED BY THE DRAIN BY THE METHYLENE BLUE TEST. THIS LED TO A FURTHER HOSPITALIZATION AFTER FOUR DAYS FOR CORRECTION OF THE ENTIRE GASTRO ANASTOMOSIS FISTULA WITH SUTURE. ONE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828978 ENDO LINEAR CUTTERS STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA N4L54R

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R