BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERED 60 ECHELON +, 440MM SHAFT

    MDR report key: 10080302 · Received May 21, 2020

    Report

    Report Number
    3005075853-2020-02688
    Event Type
    Injury
    Date Received
    May 21, 2020
    Date of Event
    February 10, 2020
    Report Date
    April 27, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036014614
    PMA / PMN Number
    K110385
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT: 6/16/2020. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: WHAT IS THE PATIENT GENDER/BMI? MALE PATIENT/ NO INFORMATION. PLEASE PROVIDE COLOR RELOADS USED IN SEQUENTIAL ORDER FROM ANTRUM TO FUNDUS. GST60G-2,GST60B-3. IS THIS THE SURGEON¿S NORMAL RELOAD SELECTION? YES. DOES THE SURGEON ROUTINELY WAIT 15 SECONDS PRIOR TO FIRING? YES. WAS BUTTRESSING MATERIAL USED? NO WERE ANY STAPLE FORMATION ISSUES NOTED? NO. WHAT WAS THE PREOPERATIVE ANTICOAGULATION REGIME FOR PATIENT? NO INFORMATION. WAS THE EXTENDED HOSPITALIZATION DUE TO OOZING DURING PROCEDURE? 1 DAY. WHAT IS THE CURRENT PATIENT STATUS? DISCHARGED.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICE: BATCH # UNK. 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. PHOTOGRAPHIC SUMMARY: UPON VISUAL INSPECTION OF TWO PHOTOS, THE FOLLOWING WAS OBSERVED: THE PHOTOS SHOW TISSUE AND WHAT APPEARS TO BE A STAPLE LINE. SLIGHT BLEEDING COULD BE OBSERVED. BASED ON THE PHOTOS REVIEWED, THE EVENT DESCRIBE IS CONFIRMED, HOWEVER NO CONCLUSION OR ROOT CAUSE COULD BE DETERMINED. HANDS ON DEVICE ANALYSIS MAY PROVIDE THE ADDITIONAL EVIDENCE NECESSARY TO CONFIRM THE ROOT CAUSE OF THE REPORTED EVENT. UPON VISUAL INSPECTION OF ONE VIDEO, THE FOLLOWING WAS OBSERVED: THE VIDEO SHOWS A STAPLE LINE AND SLIGHT BLEEDING WAS NOTED ALONG OF STAPLE LINE. AT THE 00:16 MARK A CLIP WAS PLACED ON THE STAPLE LINE. BASED ON THE VIDEO REVIEW, THE EVENT DESCRIBE IS CONFIRMED, HOWEVER NO CONCLUSION OR ROOT CAUSE COULD BE DETERMINED. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: WAS THERE ANY OTHER ISSUE NOTED WITH THE STAPLE LINE OTHER THAN BLEEDING (MALFORMED STAPLES, STAPLE LINE MISSING STAPLES, ETC.)? OOZING OF THE STAPLE LINE WAS THE ISSUE. HOW WAS THE BLEEDING CONTROLLED? APPLIED CLIPS ON STAPLE LINE. SUTURE AT FUNDUS. HOW MUCH BLOOD WAS LOST (ML)? NO DATA DID THE PATIENT REQUIRE A TRANSFUSION? NO DATA 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 HOSPITAL STAY FOR 1 DAY. 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. WHAT IS THE PATIENT GENDER/BMI? PLEASE PROVIDE COLOR RELOADS USED IN SEQUENTIAL ORDER FROM ANTRUM TO FUNDUS. IS THIS THE SURGEON¿S NORMAL RELOAD SELECTION? DOES THE SURGEON ROUTINELY WAIT 15 SECONDS PRIOR TO FIRING? WAS BUTTRESSING MATERIAL USED? WERE ANY STAPLE FORMATION ISSUES NOTED? WHAT WAS THE PREOPERATIVE ANTICOAGULATION REGIME FOR PATIENT? WAS THE EXTENDED HOSPITALIZATION DUE TO OOZING DURING PROCEDURE? WHAT IS THE CURRENT PATIENT STATUS?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON MADE SLEEVE POUCH WITH GST60G-2 AND GST60B-4, PLEE60A. AFTER LAST FIRING, THE SURGEON WENT BACK TO FIRST STAPLE TO CHECK STAPLE LINE INTEGRITY. HE FOUND STAPLE LINE OOZING. TO STOP OOZING HE USED ALMOST 30 CLIPS (LT300).EXTENDED HOSPITAL STAY FOR 1 DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541580 POWERED 60 ECHELON +, 440MM SHAFT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. PLEE60A 10705036014614

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization