BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 6987128 · Received October 30, 2017

    Report

    Report Number
    3005075853-2017-05761
    Event Type
    Injury
    Date Received
    October 30, 2017
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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-CONFORMANCE. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE, A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT THE PATIENT COMPLICATIONS ARE RELATED TO A PRODUCT DEFICIENCY OF ETHICON DEVICE?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REVIEW OF JOURNAL ARTICLE: A RETROSPECTIVE REVIEW OF PHARYNGEAL POUCH SURGERY IN 56 PATIENTS. AUTHORS: S. MIRZA, SN DUTT, SS MINHAS, RM IRVING. CITATION: ANN R COLL SURG ENGL 2002; 84: 247-251. THE AUTHORS REVIEWED THEIR UNIT¿S EXPERIENCE OF PHARYNGEAL POUCH SURGERY OVER THE PAST 10 YEARS INCLUDING DIVERTICULOSTOMY BY ENDOSCOPIC STAPLING. THE STUDY INVOLVED A RETROSPECTIVE REVIEW OF ALL CASES OF PHARYNGEAL POUCH SURGERY FROM AUGUST 1989 TO AUGUST 1999. 56 PATIENTS [39 MALE, 17 FEMALE; MEAN AGE 72 (RANGE 32-89) YEARS] UNDERWENT PHARYNGEAL POUCH SURGERY FOR SIGNIFICANT SYMPTOMS OF DISORDERED SWALLOWING. THE 56 PATIENTS UNDERWENT A NUMBER OF DIFFERENT SURGICAL TREATMENTS (TABLE 2). THESE WERE ENDOSCOPIC STAPLING (20), EXTERNAL EXCISION (23), DOHLMAN'S PROCEDURE BY DIATHERMY (9), CRICOPHARYNGEAL MYOTOMY ONLY (3), INVERSION OF POUCH (3), AND SUSPENSION OF POUCH (1). ENDOSCOPIC STAPLING DIVERTICULOTOMY WAS PERFORMED USING AN ENDOPATH ETS ENDOSCOPIC LINEAR STAPLING GUN. COMPLICATIONS IN THE ENDOSCOPIC STAPLING GROUP INCLUDE 3 PERFORATIONS. TWO OF THESE WERE DUE TO PERFORATIONS FORMED AT THE TIME OF STAPLING. ENDOSCOPIC STAPLING HAD TO BE ABANDONED AND THE PROCEDURE WAS CONVERTED INTRAOPERATIVELY TO EXTERNAL EXCISION. THE THIRD CASE WAS MANAGED SUCCESSFULLY BY CONSERVATIVE MEANS WITH NASOGASTRIC FEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768317 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention