BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PWRD 25MM CURVED CIRCULAR, 18CM SHAFT

    MDR report key: 15250127 · Received August 18, 2022

    Report

    Report Number
    3005075853-2022-05401
    Event Type
    Injury
    Date Received
    August 18, 2022
    Date of Event
    May 10, 2022
    Report Date
    August 18, 2022
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036015376
    PMA / PMN Number
    K163523
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). BATCH # UNKNOWN. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. HOWEVER, IF THE PRODUCT OR PRODUCT ID NUMBERS ARE RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS RECEIVED: WHAT TECHNIQUE WAS USED TO CREATE GASTROJEJUNOSTOMY? POWERED CIRCULAR - CDH25P. ANY MEDICAL OR SURGICAL INTERVENTION TO TREAT THE PATIENT? FOLLOWING UP WITH SURGEON. INCREASED LENGTH OF STAY. WHAT WAS THE APPEARANCE OF THE DEPLOYED STAPLES (B-FORMED, MALFORMED, GOAL POST/LEGS STRAIGHT)? STRAIGHT. WERE THERE STAPLES MISSING FROM THE STAPLE LINE? NO. WAS THE STAPLE LINE INTERRUPTED; STAPLES NOT PRESENT/VISIBLE ON ANY PORTION OF THE STAPLE LINE? NO. HOW WAS THE BLEEDING CONTROLLED? REINFORCEMENT WITH SUTURES. HOW MUCH BLOOD WAS LOST (ML)? NEED TO VERIFY WITH SURGEON. DID THE PATIENT REQUIRE A TRANSFUSION? NO. WAS THERE ANY PATIENT CONSEQUENCE OR CHANGE IN THE POST-OPERATIVE CARE OF THE PATIENT AS A RESULT OF THE EVENT? (EXTENDED HOSPITAL STAY, READMISSION, RE-OPERATION, ETC.) EXTENDED STAY. WHAT IS THE CURRENT PATIENT STATUS? NEED TO VERIFY WITH SURGEON. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FIELD AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SURGEON PERFORMED A GASTRIC BYPASS, AND THE PATIENT EXPERIENCED A GJ BLEED LATER ON THAT DAY. THERE WAS SOME BLEEDING INTRA-OPERATIVELY WHEN CREATING THE GASTRIC POUCH. THE SURGEON THOUGHT ABOUT DOING A SCOPE BUT DID NOT DO THAT. ADDITIONAL MEDICAL INTERVENTION: POST-OP CARE AND MEDICATION PRESUMABLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2026168 PWRD 25MM CURVED CIRCULAR, 18CM SHAFT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. CDH25P 10705036015376

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H