BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3870778 · Received June 12, 2014

    Report

    Report Number
    2955842-2014-03625
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 13, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE FOR THE PATIENT'S INTRA-OPERATIVE COMPLICATION. THE INSTRUMENT WAS RETURNED AND EVALUATED. A SCRATCH MARK MEASURING 0.006 IN WIDTH WAS FOUND ON THE INSTRUMENT'S TUBE REINFORCEMENT RING. FAILURE ANALYSIS (FA) WAS UNABLE TO DETERMINE IF MATERIAL WAS MISSING OR DISPLACED DUE TO THE SOFTNESS OF THE PEEK MATERIAL. FA CONCLUDED THAT THE INSTRUMENT DAMAGE WAS LIKE DUE TO MISHANDLING/MISUSE. IN ADDITION, A 0.0025 GAP BETWEEN THE TUBE REINFORCEMENT RING AND THE SHOULDER FEATURE ON THE EXTENSION TUBE WAS OBSERVED. THE TUBE REINFORCEMENT RING IS FIXED IN PLACE WITH ADHESIVE DURING ASSEMBLY. SMALL PARTICLES WERE FOUND WEDGED IN THE GAP. FA CONCLUDED THAT THE SMALL PARTICLES WERE POSSIBLY BIODEBRIS OR ADHESIVE. NO INSTRUMENT DEFICIENCIES WERE FOUND. THE ENDOWRIST INSTRUMENTS INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2014. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE SURGEON HAD TO CUT THE PATIENT'S BOWEL AND PLACE A SUTURE AFTER A PORTION OF TISSUE FROM THE PATIENT'S BOWEL BECAME STUCK BETWEEN THE TUBE REINFORCEMENT RING AND TUBE EXTENSION OF THE MCS INSTRUMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SACROCOLPOPEXY PROCEDURE, TISSUE FROM THE PATIENT'S BOWEL BECAME STUCK ALONG THE SHAFT OF THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT. AT THE TIME THE EVENT OCCURRED, THE SURGEON WAS USING THE SHAFT OF THE MCS INSTRUMENT TO RETRACT PART OF THE PATIENT'S BOWEL. AS A RESULT OF THE ISSUE, THE SURGEON HAD TO CUT PART OF THE PATIENT'S BOWEL TO REMOVE THE STUCK BOWEL TISSUE. THE SURGEON THEN PLACED A SUTURE ON THE PATIENT'S BOWEL AND COMPLETED THE DA VINCI SURGICAL PROCEDURE. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE'S RISK MANAGEMENT DEPARTMENT. ACCORDING TO THE RISK MANAGER, THE SURGEONS WHO WERE PRESENT DURING THE SURGICAL PROCEDURE INDICATED THAT THERE HAVE BEEN NO POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT. THERE WERE NO REPORTS THAT TISSUE WAS BURNED OR AN ARCING EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347601 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-12 M11130816 752

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention