BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETS45 ENDO LINEAR CUTTER 45MM

    MDR report key: 9383229 · Received November 27, 2019

    Report

    Report Number
    3005075853-2019-23843
    Event Type
    Injury
    Date Received
    November 27, 2019
    Report Date
    October 30, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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 VIA JOURNAL ARTICLE TITLE: ESTABLISHING A LAPAROSCOPIC GASTRIC BYPASS PROGRAM. AUTHOR : ALEXANDRA DRESEL, M.D.A, JOSEPH A. KUHN, M.D.A, MATTHEW V. WESTMORELAND, M.D.A, LORAYE J. TALAASEN, R.N.A, TODD M. MCCARTY, M.D. CITATION: THE AMERICAN JOURNAL OF SURGERY 184 (2002) 617¿620. THE PURPOSE OF THIS PROSPECTIVE STUDY WAS TO EVALUATE THE OUTCOMES FOR LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS IN A NEWLY DEVELOPED BARIATRIC SURGERY PROGRAM. BETWEEN DEC 2000 AND OCT 2001, A TOTAL OF 100 PATIENTS [N=100 (N=90 FEMALE, N=10 MALE, MEAN AGE 39 YEARS (RANGE 17¿58 YEARS), MEAN BMI 49 KG/M2 (RANGE37¿74 KG/M2))] UNDERWENT LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS. PNEUMOPERITONEUM WAS ESTABLISHED VIA A 12-MM OPTIVIEW TROCAR (ETHICON ENDO-SURGERY). THE LESSER SAC WAS ENTERED USING A HARMONIC SCALPEL (ETHICON ENDO-SURGERY) AND AN OPENING WAS CREATED IN THE TRANSVERSE MESOCOLON. THE LIGAMENT OF TREITZ WAS IDENTIFIED AND THE PROXIMAL JEJUNUM WAS DIVIDED 20 TO 30 CM DISTAL TO THE LIGAMENT USING A 45-MM ETS45 ENDOSCOPIC LINEAR STAPLER (ETHICON ENDO-SURGERY). THE SMALL BOWEL MESENTERY WAS DIVIDED WITH THE HARMONIC SCALPEL. A SIDE-TO-SIDE JEJUNOJEJUNOSTOMY WAS CREATED WITH TWO SEQUENTIAL FIRES OF THE ENDOSCOPIC LINEAR STAPLER AND THE ENTEROTOMY WAS CLOSED IN A SIMILAR FASHION. THE ANVIL OF THE 21-MM ENDOPATH ILS ENDOSCOPIC CIRCULAR STAPLER (ETHICON ENDO-SURGERY) WAS ATTACHED TO A CLAMP AND INSERTED INTO THE ABDOMINAL CAVITY VIA THE ASSISTANT¿S 12-MM PORT SITE. A GASTROTOMY WAS MADE IN THE BODY OF THE STOMACH USING THE HARMONIC SCALPEL AND THE ANVIL BROUGHT INTO THE STOMACH WITH A RIGHT ANGLE ENDOSCOPIC GRASPER. THE ANVIL WAS POSITIONED INSIDE THE PROPOSED POUCH AND THE HARMONIC SCALPEL USED TO MAKE A GASTROTOMY SMALL ENOUGH FOR ONLY THE POST OF THE ANVIL TO EXIT. THE CIRCULAR STAPLER WAS THEN PLACED INTO THE ABDOMINAL CAVITY VIA THE ASSISTANT¿S PORT SITE AND INSERTED INTO THE JEJUNAL LIMB VIA A JEJUNOTOMY CREATED WITH THE HARMONIC SCALPEL. THE STAPLER WAS OPENED AND ATTACHED TO THE ANVIL, CREATING AN ANTEGASTRIC, RETROCOLIC ROUX LIMB. THE STAPLER WAS FIRED, CLOSED, AND REMOVED FROM THE BODY. THE GASTROTOMY AND JEJUNOSTOMY WERE CLOSED WITH A LINEAR STAPLER. THE SKIN INCISIONS WERE ALL CLOSED WITH SUBCUTICULAR SUTURES AND DERMABOND (ETHICON) WAS PLACED ON ALL WOUNDS. POSTOPERATIVE COMPLICATIONS INCLUDED FAILURE OF THE HARMONIC SCALPEL TO FUNCTION CORRECTLY (N=2) WHICH REQUIRED CONVERSION TO OPEN RYGB; POSTOPERATIVE GASTROINTESTINAL HEMORRHAGE (N=3) WHICH REQUIRED BLOOD TRANSFUSION WITH RESOLUTION OF THE BLEEDING WITHIN 24 HOURS AND NONE OF THESE PATIENTS REQUIRED REOPERATION; LEAK AT THE PROXIMAL GASTRIC TRANSECTION LINE (N=1) REQUIRING OPERATION; LEAK AT THE DISTAL GASTRIC TRANSECTION LINE, SECONDARY TO A JEJUNOJEJUNOSTOMY OBSTRUCTION (N=1) REQUIRING OPERATION; NASOGASTRIC TUBE HAD BEEN TRANSECTED (N=1) WHICH REQUIRED REEXPLORATION; MALFUNCTION OF THE LINEAR STAPLER (N=1) WHICH REQUIRED CONVERSION TO OPEN RYGB; ANASTOMOTIC LEAK FROM A LINEAR STAPLE LINE (N=1) REQUIRING OPERATION; ANASTOMOTIC STRICTURES AT THE GASTROJEJUNOSTOMY (N=3) WHICH WAS SUCCESSFULLY ENDOSCOPICALLY DILATED; SUPERFICIAL WOUND INFECTIONS (N=2); AND PORT SITE HERNIA (N=1) THAT WAS REPAIRED PRIMARILY WITHOUT DIFFICULTY AS AN OUTPATIENT. LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS IS A TECHNICALLY CHALLENGING PROCEDURE THAT CAN BE SAFELY INTEGRATED INTO A BARIATRIC TREATMENT PROGRAM WITH GOOD RESULTS. IMPROVED OUTCOMES, SHORTER OPERATIVE TIMES, AND FEWER COMPLICATIONS ARE ASSOCIATED WITH INCREASED SURGICAL EXPERIENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1178166 ETS45 ENDO LINEAR CUTTER 45MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention