BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETS45 ENDO LINEAR CUTTER 45MM

    MDR report key: 7736672 · Received July 31, 2018

    Report

    Report Number
    3005075853-2018-11747
    Event Type
    Injury
    Date Received
    July 31, 2018
    Report Date
    July 3, 2018
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REVIEW OF JOURNAL ARTICLE: TITLE: THE APPLICABILITY OF LAPAROSCOPIC GASTRECTOMY IN THE SURGICAL TREATMENT OF GIANT DUODENAL ULCER PERFORATION. AUTHOR : MIN GYU KIM, MD, HWON KYUM PARK, MD, PHD, JAE JUNG PARK, MD, PHD, HONG GI LEE, MD, PHD, AND YOUNG SOO NAM, MD, PHD. CITATION: SURG LAPAROSC ENDOSC PERCUTAN TECH. 2012; 22 (2): 122-126. THE PRESENT STUDY AIMS TO PROVIDE AN APPLICABILITY OF LAPAROSCOPIC GASTRECTOMY USED IN THE TREATMENT OF GIANT DUODENAL ULCER PERFORATION. BETWEEN JULY 2010 AND APRIL 2011, LAPAROSCOPIC DISTAL GASTRECTOMY WITH ROUX-EN-Y GASTROJEJUNOSTOMY AND TRUNCAL VAGOTOMY WAS PERFORMED IN CONSECUTIVE 5 PATIENTS (3 MALE AND 2 FEMALE PATIENTS; AGE RANGE: 39 TO 80 YEARS OLD) WITH GIANT DUODENAL ULCER PERFORATION. IN TRUNCAL VAGOTOMY, THE LESSER OMENTUM NEAR THE GASTROESOPHAGEAL JUNCTION WAS DISSECTED BY A HARMONIC SCALPEL. THE ANTERIOR AND POSTERIOR VAGUS NERVES WERE DIVIDED BY A HARMONIC SCALPEL. AFTER LIGATION OF THE RIGHT GASTRIC ARTERY, DISSECTION OF THE POSTERIOR SIDE OF THE DUODENUM USING A HARMONIC SCALPEL WAS CONTINUED TO EXPOSE THE GASTRODUODENAL ARTERY. THE ENDOPATH ETS60 ENDOSCOPIC LINEAR STAPLER (ETHICON) WAS USED TO CREATE A SECURE DUODENAL STUMP, AND A HOOK-TIP BOVIE IS USED MAINLY IN A SEPARATE ULCER FROM HEPATODUODENAL LIGAMENT AND PANCREAS. IN PROCEDURES OF INTRACORPOREAL ROUX-EN-Y GASTOJEJUNOSTOMY, THE STOMACH WAS TRANSECTED USING 2 ENDOPATH ETS60 ENDOSCOPIC LINEAR STAPLERS THROUGH THE LEFT LOWER TROCA BY THE FIRST ASSISTANT. AFTER REMAKING THE PNEUMOPERITONEUM, 20 CM BELOW THE TREITZ LIGAMENT, THE JEJUNUM WAS DIVIDED USING AN ENDOPATH ETS60 ENDOSCOPIC LINEAR STAPLER THROUGH THE RIGHT LOWER TROCA BY AN OPERATOR. FOR RECONSTRUCT GASTROJEJUNOSTOMY, SMALL HOLES FOR ENDOPATH ETS60 ENDOSCOPIC LINEAR STAPLER WERE MADE IN THE GREATER CURVATURE SIDE OF THE REMNANT STOMACH AND THE ANTIMESENTERIC SIDE OF THE JEJUNAL LIMB. AN ENDOPATH ETS60 ENDOSCOPIC LINEAR STAPLER WAS INSERTED TO CREATE A COMMON CHANNEL BETWEEN THE REMNANT STOMACH HOLE AND THE JEJUNAL HOLE BY AN OPERATOR. AFTER CREATING A COMMON CHANNEL, THE REMNANT ANTERIOR HOLE WAS CLOSED USING ENDOPATH ETS60 ENDOSCOPIC LINEAR STAPLER BY AN OPERATOR. FOR RECONSTRUCTION JEJUNO-JEJUNOSTOMY, THE OPERATOR INSERTED THE ENDOPATH ETS45 STAPLER INTO THESE HOLES TO CREATE A COMMON CHANNEL. FINALLY, THE ANTERIOR HOLE OF THE COMMON CHANNEL WAS CLOSED WITH ENDOPATH ETS60 STAPLER. IN PROCEDURES OF EXTRACORPOREAL ANASTOMOSIS, A WOUND PROTECTOR WAS APPLIED, AND GASTROJEJUNOSTOMY WAS RECONSTRUCTED EXTRACORPOREALLY USING PROXIMATE CIRCULAR STAPLER. THE JEJUNO-JEJUNOSTOMY WAS RECONSTRUCTED BY EXTRACORPOREAL HAND-SEWN END-TO-SIDE ANASTOMOSIS REPORTED COMPLICATIONS INCLUDED PATIENT 3, A (B)(6) FEMALE PATIENT WITH WOUND INFECTION AND WAS TREATED BY CONSERVATIVE MANAGEMENT. THE AUTHORS SUGGESTED THAT THE LAPAROSCOPIC SURGERY MAY BE A GOOD SURGICAL METHOD TO IMPROVE SURGICAL OUTCOMES AND IS WORTH A TRY IN EXPERTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578881 ETS45 ENDO LINEAR CUTTER 45MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention