BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PWRD ECH FLEX 60MM EXACT CODE UNKNOWN

    MDR report key: 10288910 · Received July 17, 2020

    Report

    Report Number
    3005075853-2020-03625
    Event Type
    Injury
    Date Received
    July 17, 2020
    Report Date
    June 19, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). EVENT DATE UNK. BATCH # UNK. AS THE DEVICE WAS NOT RETURNED, AN ANALYSIS INVESTIGATION COULD NOT BE PERFORMED. A CONCLUSION COULD NOT BE REACHED AS TO WHAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: PREOPERATIVE DETECTION OF SARCOPENIC OBESITY HELPS TO PREDICT THE OCCURRENCE OF GASTRIC LEAK AFTER SLEEVE GASTRECTOMY. AUTHORS: MARTIN GAILLARD & HADRIEN TRANCHART & SOPHIE MAITRE & GABRIEL PERLEMUTER & PANAGIOTIS LAINAS & IBRAHIM DAGHER. CITATION: OBESITY SURGERY (2018) 28:2379¿2385. HTTPS://DOI.ORG/10.1007/S11695-018-3169-0. THE AIM OF THIS STUDY WAS TO PROSPECTIVELY ASSESS THE USEFULNESS OF PREOPERATIVE COMPUTED TOMOGRAPHY (CT) SCAN-DETERMINED SARCOPENIC OBESITY TO PREDICT THE OCCURRENCE OF STAPLE-LINE LEAK AFTER SLEEVE GASTRECTOMY (SG). FROM AUGUST 2013 TO JUNE 2014, 205 PATIENTS (31 MEN 174 WOMEN; MEAN AGE: 39 YEARS ± 12; MEDIAN BMI: 40.8 KG/M2 [34.2¿49.6]) UNDERWENT LAPAROSCOPIC SG AS THE PRIMARY PROCEDURE FOR MORBID OBESITY. DURING THE PROCEDURE, TRANSECTION OF THE STOMACH WAS DONE USING A 60-MM ENDOSCOPIC STAPLER OR ECHELON FLEX POWERED WITH GOLD CARTRIDGE (ETHICON, ISSY-LES-MOULINEAUX, FRANCE) AFTER PLACEMENT OF A 36-FR OROGASTRIC CALIBRATION TUBE. REPORTED COMPLICATIONS INCLUDED GASTRIC LEAK (N-?) IN WHICH 4 PATIENTS REQUIRED RELAPAROSCOPY TO EVACUATE AND DRAIN AN ABSCESS WITH SUBSEQUENT ENDOSCOPIC DRAINAGE AND IN 5 PATIENTS, AN EXCLUSIVE ENDOSCOPIC MANAGEMENT WAS SUFFICIENT, INTRA-ABDOMINAL HEMORRHAGE/HEMATOMA POSTOPERATIVELY (N-?) WHICH NECESSITATED A RELAPAROSCOPY TO CONTROL BLEEDING AND/OR EVACUATE AND DRAIN A HEMATOMA, WOUND INFECTION (N-?) WHICH WAS TREATED SURGICALLY ON BEDSIDE, AND PARIETAL HEMATOMA (N-?) WHICH WERE TREATED USING A CONSERVATIVE APPROACH THE PRESENT SERIES SUGGESTS THAT CT SCAN-DETERMINED SARCOPENIC OBESITY IS ASSOCIATED WITH INCREASED RISK OF GASTRIC LEAK AFTER SG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755460 PWRD ECH FLEX 60MM EXACT CODE UNKNOWN STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention