BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWRD ECH FLEX 60MM 34CM SHAFT

    MDR report key: 15393563 · Received September 9, 2022

    Report

    Report Number
    3005075853-2022-05923
    Event Type
    Malfunction
    Date Received
    September 9, 2022
    Date of Event
    August 15, 2022
    Report Date
    September 12, 2022
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036014324
    PMA / PMN Number
    K110385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). BATCH # UNK. INVESTIGATION SUMMARY 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 INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: 1. WAS THE DEVICE LOCKED ON TISSUE WITH THE JAWS CLOSED? IF YES, HOW WAS THE DEVICE REMOVED? YES, USE INSTRUMENT TO OPEN. 2. WHAT TROUBLESHOOTING STEPS WERE ATTEMPTED TO OPEN THE DEVICE (E.G. SQUEEZING THE CLOSING TRIGGER WHILE SIMULTANEOUSLY DEPRESSING THE ANVIL RELEASE BUTTON, KNIFE REVERSE SWITCH, MANUAL OVERRIDE)? UNKNOW. 3. DID THE JAWS EVENTUALLY OPEN? YES. 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 FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: 1. WAS THE DEVICE LOCKED ON TISSUE WITH THE JAWS CLOSED? IF YES, HOW WAS THE DEVICE REMOVED? >> YES, USE INSTRUMENT TO OPEN 2. WHAT TROUBLESHOOTING STEPS WERE ATTEMPTED TO OPEN THE DEVICE (E.G. SQUEEZING THE CLOSING TRIGGER WHILE SIMULTANEOUSLY DEPRESSING THE ANVIL RELEASE BUTTON, KNIFE REVERSE SWITCH, MANUAL OVERRIDE)? >> UNKNOWN 3. DID THE JAWS EVENTUALLY OPEN? >>YES UPON RE-REVIEW OF THE INFORMATION PROVIDED, IT WAS CONCLUDED THAT THIS EVENT DOES NOT MEET THE FDA DEFINED CRITERIA FOR A REPORTABLE EVENT AND IS BEING CONSIDERED NOT REPORTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE STAPLE STUCK WHEN USING. NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1820807 PWRD ECH FLEX 60MM 34CM SHAFT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. PSE60A 10705036014324

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown