BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 6928934 · Received October 9, 2017

    Report

    Report Number
    3005075853-2017-05320
    Event Type
    Injury
    Date Received
    October 9, 2017
    Report Date
    September 12, 2017
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    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. 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. WERE ANY OF THE POST-OPERATIVE ISSUES MENTIONED IN THIS JOURNAL ARTICLE RELATED TO ANY ETHICON PRODUCT?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REVIEW OF JOURNAL ARTICLE: TRANSUMBILICAL SLEEVE GASTRECTOMY WITH AN ACCESSORY LATERAL PORT: SURGICAL RESULTS IN 237 PATIENTS AND 1-YEAR FOLLOW-UP AUTHORS: CARLOS FARIAS, JOSE IGNACIO FERNANDEZ, CRISTIAN OVALLE, CAROLINA CABRERA, JAIME DE LA MAZA, KARIN KOSIEL, ANA MARIA MOLINA. CITATION: OBESITY SURGERY 2013;23:325-331. DOI 10.1007/S11695-012-0812-Z. THE AIM OF THIS STUDY IS TO DESCRIBE A SIMPLIFIED SURGICAL TECHNIQUE FOR SLEEVE GASTRECTOMY WITH A TRANSUMBILICAL APPROACH (TUSG) USING A LATERAL 5-MM ACCESSORY PORT AND CONVENTIONAL LAPAROSCOPIC INSTRUMENTS AND TO EVALUATE THIS PROCEDURE¿S SAFETY AND SHORT-TERM FOLLOW-UP. DATA ON ALL PATIENTS WHO UNDERWENT TUSG FROM JULY 2010 TO MAY 2012 WERE COLLECTED FROM THE AUTHORS¿ PROSPECTIVE BARIATRIC SURGERY ELECTRONIC DATABASE AND ANALYZED. INCLUSION CRITERIA WERE: BMI BETWEEN 30 AND 46 KG/M2; A XIPHO-UMBILICAL DISTANCE <25 CM; THE ABSENCE OF ABDOMINAL SCARS OF SIGNIFICANT SIZE OR OTHER ELEMENTS THAT COMPROMISED THE FINAL COSMETIC RESULT. A TOTAL OF 237 PATIENTS UNDERWENT TUSG; 221 WERE WOMEN AND 16 WERE MEN. THE MEAN AGE AND BMI WERE 36+/-10.2 YEARS AND 33.5+/-3.3 KG/M2 RESPECTIVELY. FOR THE OPERATIVE TECHNIQUE, AN ENSEAL DEVICE IS INTRODUCED IN THE LATERAL ACCESSORY TROCAR TO OBTAIN TRIANGULATION. DISSECTION OF THE GREATER CURVATURE OF THE STOMACH BEGINS 4 CM PROXIMAL TO THE PYLORUS AND MOVES UP TO THE LEFT CRUS TO OBTAIN COMPLETE GASTRIC FUNDUS LIBERATION. A TUBULAR GASTRECTOMY IS ACHIEVED WITH A GASTROINTESTINAL STAPLER ECHELON FLEX. A GREEN CARTRIDGE IS USED FOR THE ANTRUM, AND BLUE CARTRIDGES ARE USED IN THE DIRECTION TO THE ANGLE OF HIS UNTIL THE GASTRECTOMY IS COMPLETED. HEMOSTASIS OF THE STAPLER LINE IS ACHIEVED WITH METALLIC CLIPS AND SURGIFLO. THE UMBILICAL INCISION WAS INITIALLY CLOSED WITH VICRYL 1-0 AND LATER SWITCHED TO PDS 1-0. ONE PATIENT EXPERIENCED AN ANTRAL LEAK DUE TO FAILURE IN FIRING OF THE SECOND STAPLER; AND ONE PATIENT HAD HEMOPERITONEUM SECONDARY TO BLEEDING OF THE STAPLER LINE RESULTING TO HEMODYNAMIC INSTABILITY. BOTH PATIENTS UNDERWENT LAPAROSCOPIC EXPLORATION WITH SATISFACTORY OUTCOMES. THREE PATIENTS WITH HEMOPERITONEUM BUT WITHOUT HEMODYNAMIC INSTABILITY WERE TREATED WITH A LOW-MOLECULAR-WEIGHT HEPARIN SUSPENSION, VOLUME REPOSITION, AND TRANEXAMIC ACID AND INTRAVENOUS IRON SUPPLEMENTATION. ONE PATIENT PRESENTED WITH INTRAHEPATIC PORTAL VEIN THROMBOSIS 15 DAYS POSTOPERATIVELY AND WAS TREATED SUCCESSFULLY WITH LOW-MOLECULAR-WEIGHT HEPARIN AND AN ORAL ANTICOAGULANT. TWO PATIENTS HAD LATE COMPLICATIONS THAT CORRESPONDED TO INCISIONAL HERNIAS AT 4 AND 5 MONTHS POSTOPERATIVELY, RESPECTIVELY. AFTER THESE 2 PATIENTS, THE SUTURE MATERIAL USED IN THE UMBILICAL INCISION WAS CHANGED FROM VICRYL 1-0 TO PDS 1-0. NO FURTHER INCISIONAL HERNIAS WERE OBSERVED AFTER THIS CHANGE IN SUTURE MATERIAL. THE AUTHORS BELIEVE THAT THE 2 CASES OF INCISIONAL HERNIA COULD BE PREVENTED WITH THE USE OF A MORE APPROPRIATE SUTURE MATERIAL, SUCH AS PDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707699 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1