BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETS FLEX ARTICNG

    MDR report key: 1892885 · Received November 8, 2010

    Report

    Report Number
    3005075853-2010-06360
    Event Type
    Injury
    Date Received
    November 8, 2010
    Report Date
    October 15, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL FOLLOW UP: EES (B)(6) AND PRODUCT SALES REPRESENTATIVE MET WITH DR. (B)(6). DURING THE MEETING, THE SURGEON RECOUNTED THE EVENTS THAT HAD OCCURRED OVER THE PAST 2 YEARS. BASED ON HIS NUMBERS, HE HAD COMPLETED APPROXIMATELY 220 CASES AND SUGGESTED THAT ABOUT 10% OF THOSE CASES PRESENTED WITH SOME FORM OF POST-OP BLEEDING (INDICATORS: DROP IN HEMOGLOBIN, UPPER GI, VOMITING BLOOD AND/OR PASSING BLOOD IN STOOLS). THE MAJORITY OF THESE PATIENTS WERE TREATED WITH TRANSFUSION WITH NO OTHER INTERVENTION. FOUR PATIENTS REQUIRED RE-OPERATIONS, OF WHICH ONLY ONE PATIENT COULD BE DIAGNOSED WITH A BLEEDING/LEAKING STAPLE LINE. IT WAS DETERMINED INTRAOPERATIVELY THAT THE BLEEDING WAS FROM THE CIRCULAR STAPLER (COVIDIEN EEA 25 MM, 4.8) AND NOT THE ENDOCUTTER STAPLE LINES. THE OTHER THREE RE-OPERATIONS PROVIDED NO EVIDENCE OF INTRA-ABDOMINAL OR STAPLE LINE BLEEDING. DR. (B)(6) ALSO STATED THAT APPROXIMATELY HALF OF THE HEMOSTASIS ISSUES ENCOUNTERED LAST YEAR WERE MOST LIKELY ATTRIBUTED TO THE CIRCULAR STAPLER HE WAS USING (COVIDIEN EEA 25 MM, 4.8). ONCE HE ADDED BUTTRESS MATERIAL TO THE INSTRUMENT, HE NOTED A SIGNIFICANT DROP IN POST OP ISSUES. HE IS NOT ROUTINELY USING THE BUTTRESS MATERIAL, SO THIS SHOULD BE CONFIRMED TO VALIDATE OBSERVATIONS IN HEMOSTASIS ISSUES. FOR THE REMAINING HEMOSTASIS ISSUES, DR. (B)(6) FEELS IT COULD BE A COMBINATION OF HIS USE OF LOVENOX (AN ANTICOAGULANT), TORADOL (A NONSTEROIDAL ANTI-INFLAMMATORY MEDICATION WHICH HAS ANTICOAGULANT PROPERTIES) AND THE ATS45. HE MOVED FROM HEPARIN TO LOVENOX LAST YEAR DUE TO A HEPARIN BACK-ORDER. IN QUESTIONING DR. (B)(6) ON HIS OBSERVATIONS INTER-OPERATIVELY, HE INDICATED THAT HE WOULD OFTEN SEE OOZING OF THE STAPLE LINES ON THE POUCH DURING THE FIRST PORTION OF THE PROCEDURE AND THEN RETURN TO THE AREA LATER (AFTER CREATING THE JEJUNOJEJUNOSTOMY) AND FIND THE STAPLE LINES STABLE AND HEMOSTATIC. HE WOULD USE A CLIP APPLIER OCCASIONALLY TO ENSURE HEMOSTASIS WOULD BE ACHIEVED. BASED ON HIS COMMENTS, HE WOULD NOT CLOSE UNTIL HE ACHIEVED HEMOSTASIS ON ALL STAPLE LINES. AS A RESULT OF THE OUR DISCUSSION, DR. (B)(6) INDICATED THAT IT WAS IMPOSSIBLE TO PIN-POINT THE EXACT CAUSE OF THE POST-OP HEMOSTASIS ISSUE AFTER FURTHER REVIEW, ESPECIALLY CONSIDERING THE NUMBER OF VARIABLES ASSOCIATED WITH HIS TECHNIQUE AND OR PROTOCOL. HE ALSO COMMENTED THAT RETROSPECTIVELY, THERE HAS BEEN NO LEADING INDICATOR (INTRAOPERATIVELY, POST-OPERATIVELY, UPPER GI OR IN THE RE-OPERATIONS) THAT WOULD POINT DIRECTLY TO THE ATS45. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST-OPERATIVELY OF LAPAROSCOPIC GASTRIC BYPASS PROCEDURES, THE SURGEON HAS REPORTED THAT THE PATIENT REQUIRED BLOOD PRODUCTS TO ADDRESS POSSIBLE INTRA-ABDOMINAL BLEEDING. THE SURGEON FEELS THAT THE SOURCE OF THE BLEEDING IS THE STAPLE LINE DELIVERED BY THE DEVICE. NO DEVICES WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS FLEX ARTICNG STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other