BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH*STEALTH CIR STAPLER (EXACT CODE UNKNOWN)

    MDR report key: 7735088 · Received July 31, 2018

    Report

    Report Number
    3005075853-2018-11725
    Event Type
    Injury
    Date Received
    July 31, 2018
    Report Date
    July 3, 2018
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 ROBOT-ASSISTED LAPAROSCOPIC MANAGEMENT OF CARDIA CARCINOMA ACCORDING TO SIEWERT RECOMMENDATIONS AUTHOR : ALBERTO PATRITI1, GRAZIANO CECCARELLI, CECILIA CERIBELLI, ALBERTO BARTOLI, ALESSANDRO SPAZIANI1 CLAUDIO CISANO, SILVIA CIGLIANO, LUCIANO CASCIOLA CITATION: INT J MED ROBOTICS COMPUT ASSIST SURG 2011; 7: 170¿177; DOI: 10.1002/RCS.385. THE AIM OF THIS STUDY WAS TO DESCRIBE THE TECHNIQUE AND OUTCOME OF ROBOT-ASSISTED RESECTION OF PRIMARY AEG TUMOURS, IN ACCORDANCE WITH SIEWERT GUIDELINES, ASSOCIATED WITH AN EXTENDED LYMPHADENECTOMY BASED ON THE JAPANESE RECOMMENDATIONS FOR D2 LYMPHADENECTOMY. BETWEEN MAY2007 AND DEC2010, 17 PATIENTS (1:2 MALE FEMALE RATIO; AGE OF 65±12.2 YEARS) WITH OESOPHAGOGASTRIC JUNCTION (AEG) TUMOUR UNDERWENT LAPAROSCOPIC ROBOT-ASSISTED OESOPHAGO¿GASTRIC RESECTION WITH LYMPH NODE DISSECTION. IN TRAN-HIATAL EXTENDED TOTAL GASTRECTOMY (N=14), COLO-EPIPLOIC DIVISION WAS PERFORMED USING ULTRACISION HARMONIC SCALPEL. THE POSTPYLORIC DUODENAL REGION WAS DISSECTED AND TRANSECTED USING 45 MM CARTRIDGE ENDOSTAPLER (BLUE LOAD) WHICH WAS ALSO USED IN JEJUNAL STUMP CLOSURE AND SIDE-TO-SIDE JEJUNOJEJUNAL ANASTOMOSIS IN ROUX-EN-Y RECONSTRUCTION. NO. 25 PROXIMATE ILS CIRCULAR STAPLER WAS ATTACHED TO THE OESOPHAGEAL STUMP AND USED IN END-TO-SIDE ANTECOLIC OESOPHAGEAL-JEJUNAL ANASTOMOSIS. IN TRANSTHORACIC DISTAL OESOPHAGECTOMY WITH PROXIMAL GASTRIC RESECTION (N=1), THE INTRATHORACIC OESOPHAGO¿GASTRIC ANASTOMOSIS IS CARRIED OUT AS DESCRIBED FOR THE TRANSHIATAL APPROACH TO DISTAL OESOPHAGECTOMY WITH PROXIMAL GASTRIC RESECTION. POSTOPERATIVELY, ONE PATIENT HAD DUODENAL STUMP LEAKAGE WHICH WAS MANAGED CONSERVATIVELY, ONE PATIENT HAD SMALL LEAK OF THE OESOPHAGEAL-JEJUNAL ANASTOMOSIS TREATED WITH ROUTINE POSTOPERATIVE SWALLOW AND RESUMED LIQUID DIET IN POD6, AND ONE PATIENT HAD OESOPHAGEAL-JEJUNAL ANASTOMOSIS FAILURE. ROBOT-ASSISTED LAPAROSCOPIC RADICAL SURGERY OF THE OESOPHAGO¿GASTRIC JUNCTION IS FEASIBLE AND SAFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575985 ENDOPATH*STEALTH CIR STAPLER (EXACT CODE UNKNOWN) LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention