BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOWEL GRASPER

    MDR report key: 6062302 · Received October 27, 2016

    Report

    Report Number
    2955842-2016-00763
    Event Type
    Injury
    Date Received
    October 27, 2016
    Date of Event
    September 27, 2016
    Report Date
    September 27, 2016
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ISI HAS RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS REPLICATED/CONFIRMED THE REPORTED COMPLAINT THAT WHEN THE TINES OF THE BOWEL GRASPER INSTRUMENT ARE ROLLED, A LATERAL GIVE OR MOVEMENT IS NOTICED. THE INSTRUMENT WAS MANUALLY MANIPULATED AND FOUND TO EXHIBIT A GRINDING/JERKING MOTION VIA MANUAL ACTUATION. THE INSTRUMENT'S HOUSING WAS REMOVED AND THE INSTRUMENT BEARINGS WERE FOUND TO BE CORRODED/CONTAMINATED. THE KNOWN COMMON CAUSE OF THIS FAILURE IS DUE TO IMPROPER CLEANING. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2016. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON CLAIMED THAT THE BOWEL GRASPER INSTRUMENT CAUSED A BOWEL TEAR THAT REQUIRED REPAIR. HOWEVER, AT THIS TIME, THE ROOT CAUSE OF THE BOWEL INJURY IS UNKNOWN. BASED ON THE FAILURE ANALYSIS OF THE INSTRUMENT, THERE WAS NO INDICATION THAT A MALFUNCTION OF THE DEVICE OCCURRED SINCE THE GRINDING/JERKING MOTION FOUND DURING EVALUATION WAS DETERMINED TO BE DUE TO IMPROPER CLEANING. FURTHERMORE, THE SURGEON DID NOT ALLEGE NON-INTUITIVE MOTION OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED GASTRIC BYPASS PROCEDURE, THE BOWEL GRASPER INSTRUMENT ALLEGEDLY TORE THE SMALL BOWEL WHILE THE SURGEON WAS RUNNING THE BOWEL. ON (B)(6) 2016, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR), AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE BOWEL INJURY OCCURRED TOWARDS THE BEGINNING OF THE SURGICAL PROCEDURE WHILE THE SURGEON WAS CREATING THE JJ ANASTOMOSIS OR JEJUNO-JENJUNAL ANASTOMOSIS. AS PART OF THE PLANNED SURGICAL PROCEDURE, THE SURGEON RAN THE BOWEL. DURING THE PROCESS OF MANIPULATING AND GRABBING THE BOWEL WITH THE BOWEL GRASPER INSTRUMENT, AN APPROXIMATE 4 CM LACERATION OR TEAR OF THE BOWEL OCCURRED. IT IS UNCLEAR HOW OR WHY THE BOWEL INJURY OCCURRED. THE SURGEON REPAIRED THE BOWEL INJURY WITH SUTURES AND THE SURGICAL PROCEDURE WAS COMPLETED. ACCORDING TO THE CSR, NO POST-OPERATIVE COMPLICATIONS WERE REPORTED. AFTER THE EVENT OCCURRED, THE SURGEON REPORTEDLY INSPECTED THE BOWEL GRASPER INSTRUMENT AND INDICATED THAT WHEN THE TINES OF THE INSTRUMENT ARE ROLLED, A LATERAL GIVE OR MOVEMENT IS NOTICED. HOWEVER, THE CSR INDICATED THAT THERE WAS NO ALLEGATION BY THE SURGEON THAT THE INSTRUMENT HAD NON-INTUITIVE MOTION DURING THE SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712452 BOWEL GRASPER ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420177-06 S10160725 625

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention