BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 6957812 · Received October 18, 2017

    Report

    Report Number
    3005075853-2017-05519
    Event Type
    Injury
    Date Received
    October 18, 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: SIGNIFICANT WEIGHT LOSS AND RAPID RESOLUTION OF DIABETES AND DYSLIPIDEMIA DURING SHORT-TERM FOLLOW-UP AFTER LAPAROSCOPIC SLEEVE GASTRECTOMY AUTHORS: A. PERATHONER, A. WEISSENBACHER, R. SUCHER, E. LAIMER, J. PRATSCHKE, R. MITTERMAIR CITATION: OBESITY SURGERY 2013;23:1966-1972. DOI 10.1007/S11695-013-1038-4 THE AIM OF THIS SINGLE-CENTER RETROSPECTIVE ANALYSIS WAS TO REVIEW THE EARLY RESULTS OF LAPAROSCOPIC SLEEVE GASTRECTOMY (SG) TO ASSESS WEIGHT LOSS AND FEASIBILITY IN THE AUTHORS¿ CENTER. THIS ANALYSIS INCLUDES ALL CONSECUTIVE PATIENTS WHO UNDERWENT SG FROM JANUARY 2006 TO DECEMBER 2011. THE STUDY INCLUDES 93 PATIENTS (63 FEMALE AND 25 MALE PATIENTS). MEDIAN AGE WAS 46 YEARS (RANGE 19-73). THE MEAN PREOPERATIVE BMI WAS 44.1+/-6.9 KG/M2 (RANGE 34.8-72.9). SLEEVE GASTRECTOMY WAS DONE USING A LINEAR STAPLER (ECHELON ENDOPATH STAPLER, ECHELON FLEX ENDOPATH STAPLER, GREEN/GOLD CARTRIDGE). THREE PATIENTS UNDERWENT RELAPAROTOMY (N=2) OR RELAPAROSCOPY (N=1) BECAUSE OF AN INTRAABDOMINAL BLEEDING ON THE FIRST POSTOPERATIVE DAY. THESE 3 CASES OF BLEEDING WERE CAUSED BY LACERATION OF A GASTROEPIPLOIC AND A LINEAL VESSEL, AND ONLY ONE BLEEDING WAS ASSOCIATED TO THE STAPLE LINE. TWO PATIENTS DEVELOPED A PROXIMAL STAPLE LINE LEAKAGE, WHICH WERE SUCCESSFULLY TREATED ENDOSCOPICALLY WITH A STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736854 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention