BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERED 60 ECHELON +, 440MM SHAFT

    MDR report key: 14602680 · Received June 6, 2022

    Report

    Report Number
    3005075853-2022-03632
    Event Type
    Injury
    Date Received
    June 6, 2022
    Date of Event
    May 10, 2022
    Report Date
    June 6, 2022
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036014614
    PMA / PMN Number
    K110385
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). BATCH #: UNK. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. ONCE ADDITIONAL INFORMATION HAS BEEN RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED: WHAT WAS THE PRODUCT CODE OF THE CARTRIDGE USED? WHAT WAS THE APPEARANCE OF THE DEPLOYED STAPLES (B-FORMED, MALFORMED, GOAL POST/LEGS STRAIGHT)? WERE THERE STAPLES MISSING FROM THE STAPLE LINE? WAS THE STAPLE LINE INTERRUPTED; STAPLES NOT PRESENT/VISIBLE ON ANY PORTION OF THE STAPLE LINE? HOW WAS THE BLEEDING CONTROLLED? HOW MUCH BLOOD WAS LOST (ML)? DID THE PATIENT REQUIRE A TRANSFUSION? 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.) WHAT IS THE CURRENT PATIENT STATUS? WHAT WAS THE PRODUCT CODE OF THE CARTRIDGES USED FOR THE CREATION OF POUCH AND OF THE GASTROJEJUNOSTOMY? WHAT TECHNIQUE WAS USED TO CREATE GASTROJEJUNOSTOMY: ECHELON, CIRCULAR OR HANDSEWN? AMY MEDICAL OR SURGICAL INTERVENTION TO TREAT THE PATIENT? ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING DOCUMENTATION COULD NOT BE COMPLETED AS THE LOT/BATCH NUMBER WAS NOT PROVIDED. AS PART OF ETHICON'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 08/18/2022. 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: PER OUR MEDICAL TEAM - WHAT WAS THE PRODUCT CODE OF THE CARTRIDGES USED FOR THE CREATION OF POUCH AND OF THE GASTROJEJUNOSTOMY? GST60B - BLUE RELOADS WHAT TECHNIQUE WAS USED TO CREATE GASTROJEJUNOSTOMY: ECHELON, CIRCULAR OR HANDSEWN? 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.

    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. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184428 POWERED 60 ECHELON +, 440MM SHAFT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. PLEE60A 10705036014614

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H