BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH*STEALTH CIR STAPLER (EXACT CODE UNKNOWN)

    MDR report key: 9357043 · Received November 21, 2019

    Report

    Report Number
    3005075853-2019-23670
    Event Type
    Injury
    Date Received
    November 21, 2019
    Date of Event
    January 1, 2003
    Report Date
    October 28, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2003. MEDICAL DEVICE: BATCH # UNK. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED. [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LITERATURE ENTITLED: SURGICAL CURE FOR EARLY RECTAL CARCINOMA AND LARGE ADENOMA: TRANSANAL ENDOSCOPIC MICROSURGERY (USING ULTRASOUND OR ELECTROSURGERY) COMPARED TO CONVENTIONAL LOCAL AND RADICAL RESECTION AUTHORS: C. LANGER, T. LIERSCH, M. SUSS, A. SIEMER, P. MARKUS, B. M. GHADIMI, L. FUZESI H. BECKER CITATION: INT J COLORECTAL DIS (2003); 18:222¿229. DOI: 10.1007/S00384-002-0441-4. THE PURPOSE OF THIS STUDY WAS TO EVALUATE EXPERIENCES WITH LARGE ADENOMAS AND EARLY RECTAL CARCINOMAS AT A SINGLE TERTIARY CARE CENTER. SPECIFICALLY, THIS STUDY COMPARED OUTCOME OF FOUR DIFFERENT SURGICAL TECHNIQUES. THIS RETROSPECTIVE STUDY INVOLVES 182 OPERATIONS PERFORMED BETWEEN 1990 AND 2001 ON 162 PATIENTS WITH EARLY RECTAL CARCINOMA (PT1, G1/2) OR ADENOMA TO COMPARE THE OUTCOME FOLLOWING FOUR DIFFERENT KINDS OF SURGICAL RESECTION TECHNIQUES; RS GROUP:27 (SEX RATIO: M/F 1.3; AGE: 67.3±12.7 YEARS) ANTERIOR OR ABDOMINOPERINEAL RESECTION WAS PERFORMED; TP GROUP, 76 (SEX RATIO: M/F 0.6; AGE: 64.7±17.1 YEARS) CONVENTIONAL TRANSANAL RESECTION USING PARK¿S RETRACTOR WAS PERFORMED, TEM-ES GROUP, 45 (SEX RATIO: M/F 1.7; AGE: 66.6±10.5 YEARS) TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) WITH ELECTROSURGERY WAS PERFORMED; AND TEM-UC GROUP, 34 (SEX RATIO: M/F 0.9; AGE: 62.1±11.1 YEARS) TRANSANAL ENDOSCOPIC MICROSURGERY WITH ULTRACISION (ETHICON) WAS PERFORMED. DURING THE RADICAL SURGERY FOR THE RS GROUP, THE STRAIGHT END-TO-END ANASTOMOSIS IN THE DOUBLE-STAPLING TECHNIQUE WAS SUTURED USING A CURVED CIRCULAR STAPLER (ETHICON). FOR THE TEM-UC GROUP, THE LAST 34 TEM OPERATIONS (JULY 1999 TO DECEMBER 2001) WERE PERFORMED EXCLUSIVELY WITH ULTRACISION (ETHICON). BY PULSING A PIEZOELECTRIC CRYSTAL WITH AN ELECTRICAL CURRENT, UC CONVERTS ELECTRICAL ENERGY INTO MECHANICAL ENERGY, VIBRATING THE BLADE OF THE INSTRUMENT WITH A CONSTANT FREQUENCY OF 55.5 KHZ. UC DISSECTS,COAGULATES, AND CUTS TISSUE WITHOUT VISIBILITY BEING IMPAIRED BY SMOKE. IN CASES OF PERFORATION OF THE PERITONEUM OR OF CLOSING THE RECTAL WALL DEFECT CONTINUOUSLY, ABSORBABLE SUTURES AND SILVER CLIPS (3-0 PDS, ETHICON) WERE USED. REPORTED COMPLICATION IN THE RS GROUP INCLUDED LEAKAGE (N-1) IN WHICH THE PATIENT UNDERWENT OPERATIVE REVISION. THIS PATIENT DIED OF A GENERAL SEPSIS AFTER THE ANASTOMOTIC LEAKAGE FOLLOWING A LOW ANTERIOR RESECTION. REPORTED COMPLICATION IN THE TEM-ES GROUP INCLUDED BLEEDING (N-?). REPORTED COMPLICATION IN THE TEM-UC GROUP INCLUDED LEAKAGE (N-1) AND BLEEDING (N-1). IN CONCLUSION, TEM USING UC SEEMS TO BE THE TECHNIQUE OF CHOICE. TP LEADS TO AN UNACCEPTABLE RECURRENCE RATE, AND RS RESULTS IN A HIGHER INCIDENCE OF COMPLICATION AND IMPAIRMENT OF LIFE QUALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1146266 ENDOPATH*STEALTH CIR STAPLER (EXACT CODE UNKNOWN) STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention