BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH STEALTH ENDO/CONVENTIONAL CIRCULAR STAPLER

    MDR report key: 79487 · Received January 9, 1997

    Report

    Report Number
    1628808-1997-00009
    Event Type
    Malfunction
    Date Received
    January 9, 1997
    Date of Event
    December 11, 1996
    Report Date
    January 7, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFO RECEIVED AND THE VISUAL AND FUNCTIONAL RESULTS, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE INSTRUMENT WAS RELOADED AND FIRED. IT FIRED AND FORMED STAPLES AS DESIGNED AROUND THE ENTIRE STAPLE RING. ADDITIONALLY, THE STAPLE HEIGHTS WERE MEASURED AND FOUND TO BE CONFORMING TO MFG REQUIREMENTS. THE REPORTED INCIDENT OF MALFORMED STAPLES COULD NOT BE RECREATED. MFG AND ENGINEERING HAVE BEEN NOTIFIED OF THE REPORTED INCIDENT. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT IS REPORTED IN ORDER TO CONTINUOUSLY IMPROVE CO'S PRODUCTS.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A LOW ANTERIOR RESECTION THE ECS29 DID NOT FORM STAPLES COMPLETELY. THE ANASTOMSIS LEAKED AND WAS OVERSEWN WITH SUTURE. THERE WAS NO CONSEQUENCE TO THE PT. 12/13/96 1310 THE SURGEON CALLED BACK STATING WHEN SHE USED THE ECS29 DURING A LOW ANTERIOR RESECTION PROCEDURE. THE SURGEON SAID WHEN SHE FIRED THE DEVICE IT APPEARED TO FIRE FINE. THE SURGEON REPORTED SHE HEARD A CRUNCH SOUND WHEN THE INSTRUMENT WAS FIRED. UPON OPENING THE INSTRUMENT THE SURGEON STATED THE DONUTS WERE COMPLETE. THE SURGEON SAID THE DISTAL PART OF THE ANASTOMOSIS WAS FINE, BUT PROXIMALLY THE STAPLES WERE MALFORMED. THE SURGEON REPORTED SHE PERFORMED A LEAK TEST WITH AIR INSUFFLATION AND THE ANASTOMOSIS LEAKED PROXIMALLY. THE SURGEON SAID SHE REINFORCED THE ANASTOMOSIS WITH 3-0 SILK SUTURES AND PERFORMED ANOTHER LEAK TEST AND IT WAS FINE. THHE SURGEON REPORTED THERE WAS NO CONSEQUENCE TO THE PT AND THE PT DID FINE POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH STEALTH ENDO/CONVENTIONAL CIRCULAR STAPLER CIRCULAR STAPLERS GAG ETHICON ENDO-SURGERY, INC. N UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention