BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIRCULAR MECH STD 29MM

    MDR report key: 15052212 · Received July 19, 2022

    Report

    Report Number
    3005075853-2022-04666
    Event Type
    Injury
    Date Received
    July 19, 2022
    Date of Event
    January 1, 2022
    Report Date
    July 19, 2022
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE OF EVENT: ONLY EVENT YEAR KNOWN: 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 OBTAINED: WHERE WITHIN THE GAP SETTING SCALE WAS THE ORANGE INDICATOR PRIOR TO FIRING? IN THE ORANGE AREA. WHAT CONFIRMATION WAS RECEIVED THAT THE DEVICE WAS FULLY FIRED? CRACK. DID THE DEVICE STAPLE? YES. WAS THE STAPLE LINE COMPLETE? YES. WERE THERE ANY STAPLES MISSING FROM THE STAPLE LINE? NO. WHAT WAS THE SHAPE OF THE STAPLES (B-FORMATION, IRREGULAR, LEGS STRAIGHT)? B SHAPE WERE THE STAPLES DEPLOYED INTO THE TISSUE? YES. WERE THE STAPLES SEEN IN THE SURGICAL FIELD? UNKNOWN. DID THE DEVICE CUT? JYES. WAS THE CUT LINE FULLY CIRCUMFERENTIAL AROUND THE TARGET TISSUE? YES. IF THE DEVICE FULLY CUT, WERE BOTH TISSUE DONUTS PRESENT? YES. IF THE DEVICE FULLY CUT, WERE BOTH DONUTS COMPLETE? YES. HOW MANY COUNTER-CLOCKWISE REVOLUTIONS WERE USED TO OPEN THE DEVICE? ½ TO ¾ 16. HOW WAS IT CONFIRMED THAT THE ANVIL WAS FREE FROM THE TISSUE PRIOR TO REMOVING? UNKNOWN. AFTER FIRING WAS THE ADJUSTING KNOB TURNED ½ TO ¾ REVOLUTIONS? YES. WAS THE DEVICE ROTATED 90 DEGREES IN BOTH DIRECTIONS TO ENSURE THE ANVIL WAS FREE FROM THE TISSUE? YES. WHO FIRED THE DEVICE? DIFFERENT SURGEON. WHO REMOVED THE DEVICE? THE SURGEON WHO CLOSED THEANASTOMOSIS. WAS THE SAFETY RESET PRIOR TO REMOVAL? UNKNOWN. WHAT WAS THE USERS EXPERIENCE WITH THE DEVICE? VERY EXPERIENCED USER. EXCLUSIVELY EXPERIENCED OPERATORS/SENIOR PHYSICIAN. 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 WERE THE INDICATIONS FOR SURGERY? WHAT SURGICAL PROCEDURE WAS PERFORMED? DID THE PATIENT RECEIVE ANY PREOPERATIVE CHEMOTHERAPY OR RADIATION? WERE THERE ANY ISSUES EXPERIENCED WITH THE DEVICE IN THE INITIAL SURGICAL PROCEDURE? WHAT HEALTHCARE PROFESSIONAL FIRED THE DEVICE AND WHAT IS HIS/HER EXPERIENCE WITH THE DEVICE? WHERE IN THE GREEN GAP SETTING SCALE WAS THE INDICATOR LOCATED PRIOR TO FIRING (LOW-B, MIDDLE-B, OR HIGH-B)? DID THE HEALTHCARE PROFESSIONAL WAIT 15 SECONDS AFTER CLOSING THE DEVICE AND THEN RETIGHTEN PRIOR TO FIRING? WAS THE DEVICE DIFFICULT TO CLOSE? WAS THE DEVICE DIFFICULT TO FIRE? HOW MANY COUNTER-CLOCKWISE REVOLUTIONS OF THE ADJUSTING KNOB WERE USED TO OPEN THE DEVICE? DID THE HEALTHCARE PROFESSIONAL RECEIVE AUDIBLE & TACTILE FEEDBACK WHEN FIRING THE DEVICE? WERE THE DONUTS INSPECTED? IF SO, PLEASE DESCRIBE. WAS A COMPLETE TRANSECTION OF THE WHITE BREAKAWAY WASHER VISUALLY CONFIRMED? WERE THERE ANY ISSUES NOTED WITH STAPLE FORMATION AT ANY POINT THROUGHOUT THE CARE OF THE PATIENT? IF SO, PLEASE DESCRIBE THE SHAPE AND LOCATION. WAS THE STOMA PLACED DURING THE INITIAL PROCEDURE OR WAS THE PATIENT RE-OPERATED ON? IF THE STOMA WAS PLACED DURING THE INITIAL PROCEDURE, WAS THIS PRE-PLANNED? IF THIS WAS A RE-OP, WHAT SIGNS OR SYMPTOMS DID THE PATIENT HAVE THAT LEAD THEM BACK TO THE OR? IF RE-OP WAS DONE, HOW MANY DAYS POST-OP WAS THE RE-OP? WHERE THERE ANY ISSUES FOUND DURING THE RE-OP AND IF SO, HOW WERE THEY ADDRESSED? WHAT IS THE CURRENT STATUS OF THE PATIENT? 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.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 11/09/2022 H11: CORRECTED DATE = H6 OMITTED ON PREVIOUS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TUMOR DEEP RECTUM. INSUFFICIENCY AFTER USAGE. POST-OP PATIENT HAD A VACUUM SPONGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1718278 CIRCULAR MECH STD 29MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention