BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOWEL GRASPER

    MDR report key: 5669898 · Received May 20, 2016

    Report

    Report Number
    2955842-2016-00359
    Event Type
    Injury
    Date Received
    May 20, 2016
    Date of Event
    April 19, 2016
    Report Date
    April 21, 2016
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ISI HAS RECEIVED THE BOWEL GRASPER INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. A VISUAL INSPECTION OF THE INSTRUMENT WAS CONDUCTED AND NO EVIDENCE OF A BURR WAS FOUND ON THE GRIP SURFACES. THE INSTRUMENT'S GRIP TEETH HAD NO DAMAGE AND WERE ALIGNED PROPERLY. 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 GASTRIC BYPASS PROCEDURE, THE TEETH OF THE BOWEL GRASPER INSTRUMENT ALLEGEDLY CAUSED A BOWEL INJURY THAT WAS REPAIRED WITH SUTURES. HOWEVER, THE CAUSE OF THE BOWEL INJURY IS UNKNOWN. THE BOWEL GRASPER INSTRUMENT WAS EVALUATED AND NO FAILURES WERE OBSERVED WITH THE INSTRUMENT'S TEETH OR GRIPS.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED GASTRIC BYPASS PROCEDURE A SHARP BURR AT THE TIP OF THE BOWEL GRASPER INSTRUMENT ALLEGEDLY CAUSED A TEAR IN THE PATIENT'S SMALL BOWEL. ON 05/16/2016, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE CSR WAS PRESENT DURING A PART OF THE DA VINCI-ASSISTED SURGICAL PROCEDURE BUT WAS NOT PRESENT WHEN THE EVENT OCCURRED. THE CSR SPOKE TO THE SURGEON REGARDING THE EVENT. ACCORDING TO THE SURGEON, WHILE HE WAS RUNNING THE BOWEL WITH THE BOWEL GRASPER INSTRUMENT, THE TEETH OF THE INSTRUMENT ALLEGEDLY CAUSED A 5-8 MM HOLE IN THE SMALL BOWEL. THE SURGEON WAS ABLE TO REPAIR THE BOWEL INJURY BY OVERSEWING THE DEFECT WITH SUTURES. AFTER THE REPAIR WAS PERFORMED, THE SURGEON SUCCESSFULLY COMPLETED THE DA VINCI-ASSISTED GASTRIC BYPASS PROCEDURE WITH A REPLACEMENT BOWEL GRASPER INSTRUMENT. TO HIS KNOWLEDGE, NO POST-OPERATIVE COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324949 BOWEL GRASPER ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420177-06 S10160209 709

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention