BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)

    MDR report key: 9480917 · Received December 17, 2019

    Report

    Report Number
    3005075853-2019-24447
    Event Type
    Injury
    Date Received
    December 17, 2019
    Report Date
    November 21, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). EVENT DATE: UNK. 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. 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. DOES THE SURGEON/AUTHOR BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: LAPAROSCOPIC SLEEVE GASTRECTOMY WITHOUT OVER-SEWING OF THE STAPLE LINE IS EFFECTIVE AND SAFE. AUTHORS: MOJMIR KASALICKY, RADEK DOLEZEL, EVA VERNEROVA, MARTIN HALUZIK. CITATION: DOI: 10.5114/WIITM.2014.40387. THE PURPOSE OF THIS RETROSPECTIVE STUDY WAS TO ANALYSE THE SAFETY OF THE LAPAROSCOPIC SLEEVE GASTRECTOMY (LSG) PROCEDURE WITHOUT OVER-SEWING OF THE STAPLE LINE AND THE IMPACT OF THE DEGREE OF SLEEVE RESTRICTION ON LONG-TERM WEIGHT-REDUCING EFFECTS. A TOTAL OF 207 MORBID OBESE PATIENTS [N=48 MEN, N=159 WOMEN, AVERAGE AGE OF 43.4 YEARS (RANGE 19¿65 YEARS), AVERAGE BMI 44.9 KG/M2 (RANGE 34.1¿71.9 KG/M2)] UNDERWENT LSG WITHOUT OVER-SEWING THE STAPLE LINE. PATIENTS WERE DIVIDED INTO TWO GROUPS BY DATE AND TYPE OF SURGERY: GROUP 1 PATIENTS WITH MINOR SLEEVE RESTRICTION WERE OPERATED ON IN 2006¿2008; GROUP 2 PATIENTS WITH MAJOR SLEEVE RESTRICTION WERE OPERATED ON IN 2009¿2012. FOR TISSUE AND VESSEL DISSECTION AN ULTRASONIC DISSECTION DEVICE WAS USED (HARMONIC SCALPEL, ETHICON ENDO-SURGERY). DISSECTION OF ADHESIONS BETWEEN THE BACK OF THE STOMACH WALL AND PANCREAS WAS CARRIED OUT, FOLLOWED BY VERY CAREFUL RESECTION OF THE GASTRIC WALL. IN THE MAJORITY OF CASES A LINEAR STAPLER (ECHELON60, ETHICON ENDO-SURGERY) WITH BLUE CARTRIDGES WAS USED. WE RECOMMEND HOLDING ON FOR APPROXIMATELY 60 SECONDS AFTER STAPLER CLOSURE AND BEFORE FIRING IT, AS WELL AS BEFORE REMOVING THE STAPLER. SPORADICALLY, ONLY IN CASE OF A SMALL DIFFUSE BLOOD LEAK WAS THE RESECTION/STAPLE LINE COVERED WITH 100% OXIDIZED CELLULOSE (SURGICEL, ETHICON). POSTOPERATIVE COMPLICATIONS INCLUDED BLEEDING FROM THE SPLEEN (N=1) THAT WAS INJURED DURING DISSECTION, HAD CONVERSION FROM LAPAROSCOPY TO OPEN SURGERY; INTRA-ABDOMINAL BLEEDING FROM THE RESECTION LINE (N=1) REQUIRING LAPAROSCOPIC REVISION WITHIN 4 H AFTER SURGERY; BLEEDING POINT IN THE RESIDUAL ANTRUM WAS OVER-SEWN WITH A SINGLE INTERRUPTEDR ESORBABLE STITCH; LEAK FROM THE STAPLE LINE (N=?) TREATED BY CT-CONTROLLED DRAINAGE AND COVERED WITH 100% OXIDIZED CELLULOSE SURGICEL. THREE-YEAR FOLLOW-UP COMPLICATIONS INCLUDED MILD HEART BURN (N=?) WHICH DISAPPEARED WITHIN 6¿9 MONTHS; AND HEARTBURN PERSISTED IN LONG-TERM FOLLOW-UP (N=?) WHICH THEY HAVE TO BE ON PPI. CAREFULLY PERFORMED LSG WITHOUT OVER-SEWING THE STAPLE LINE IS FEASIBLE AND SAFE. A BETTER WEIGHT-REDUCING EFFECT WAS PRESENT IN PATIENTS WITH MAJOR SLEEVE RESTRICTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1272384 HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL GEI ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention