BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 6961186 · Received October 19, 2017

    Report

    Report Number
    3005075853-2017-05520
    Event Type
    Injury
    Date Received
    October 19, 2017
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 BELIEVE THE POST-OPERATIVE COMPLICATIONS OUTLINED IN THIS JOURNAL ARTICLE ARE ASSOCIATED WITH AN ALLEGED DEFICIENCY OF AN ETHICON PRODUCT?

    Description of Event or Problem · 1

    IT WAS REPORTED DURING REVIEW OF JOURNAL ARTICLE: INTRAPERITONEAL ROPIVACAINE IRRIGATION IN PATIENTS UNDERGOING BARIATRIC SURGERY: A PROSPECTIVE RANDOMIZED CLINICAL TRIAL AUTHORS: JAIME RUIZ-TOVAR, JUAN GONZALEZ, ALEJANDRO GARCIA, CONSUELO CRUZ, SARA RIVAS, MONTIEL JIMENEZ, CARLOS FERRIGNI, MANUEL DURAN CITATION: OBESITY SURGERY 201;26:2616-2621. DOI 10.1007/S11695-016-2142-Z. THE AIM OF THIS STUDY WAS TO ANALYZE THE ANALGESIC EFFECT OF INTRAPERITONEAL ROPIVACAINE INFUSION IN PATIENTS UNDERGOING BARIATRIC SURGERY. A PROSPECTIVE RANDOMIZED CLINICAL TRIAL OF ALL THE PATIENTS UNDERGOING LAPAROSCOPIC SLEEVE GASTRECTOMY (LSG) OR LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS (LRYGB) BETWEEN JANUARY AND NOVEMBER 2015 WAS PERFORMED. PATIENTS WERE RANDOMIZED TO EXPERIMENTAL (EG: THOSE PATIENTS UNDERGOING INTRAPERITONEAL ROPIVACAINE IRRIGATION) AND CONTROL GROUPS (CG: THOSE UNDERGOING INTRAPERITONEAL IRRIGATION WITH NORMAL SALINE). ONE HUNDRED TEN PATIENTS WERE INCLUDED, 83 LRYGB AND 27 LSG. LSG AND LRYGB WERE PERFORMED USING A LINEAR STAPLER (ECHELON FLEX). THERE WERE 55 PATIENTS EACH IN THE CG AND EG GROUPS. THERE WERE 75 FEMALES AND 35 MALES WITH A MEAN AGE OF 45.3+/-10.2 YEARS AND A MEAN BMI OF 45.8+/-8.1 KG/M2. COMPLICATIONS IN THE CG GROUP CONSISTED OF 1 CASE OF HEMOPERITONEUM AFTER LSG AND ONE LEAK IN THE GASTROJEJUNAL ANASTOMOSIS AFTER LRYGB. COMPLICATIONS IN THE EG GROUP INCLUDE 1 CASE OF STAPLE LINE LEAK IN THE GASTROESOPHAGEAL JUNCTION AFTER LSG AND 1 LEAK IN THE ENTERO-ENTERAL ANASTOMOSIS. EXCEPTING THE CASE OF THE STAPLE LINE LEAK THAT WAS SATISFACTORILY MANAGED WITH AN ENDOSCOPIC STENT PLACEMENT, THE REST OF THE PATIENTS PRESENTING WITH POSTOPERATIVE COMPLICATIONS UNDERWENT RELAPAROSCOPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741429 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention