BEUDAMED
    FDA Adverse Event Summary report: N

    12X150MM KII SHIELDED BLADED ACCESS SYS THREADED

    MDR report key: 2222728 · Received July 8, 2011

    Report

    Report Number
    2027111-2011-00064
    Date Received
    July 8, 2011
    Date of Event
    January 12, 2011
    Report Date
    July 8, 2011
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE DEVICE INVOLVED IN THE INCIDENT WAS NOT RETURNED FOR EVALUATION; HOWEVER, THE REPORT STATED THE DEVICE WAS USED WITH A DA VINCI SURGICAL ROBOT SYSTEM. THE C0R69 THREADED CANNULA MODEL IS NOT QUALIFIED FOR USE WITH THE DA VINCI ROBOT SYSTEM. APPLIED RECOMMENDS REVIEW OF THE INTUITIVE SURGICAL, INC.'S (DA VINCI ROBOT MANUFACTURER) INSTRUMENTS AND ACCESSORIES TO UNDERSTAND WHICH APPLIED MEDICAL TROCARS HAVE BEEN VALIDATED FOR USE WITH THE DA VINCI ROBOT AND THE CORRESPONDING ADAPTERS. INTUITIVE SURGICAL, INC. SUPPLIES A VALIDATED MOUNT (MODEL# 371528) FOR APPLIED MEDICAL NON-THREADED TROCAR MODELS. THIS DOCUMENT REPRESENTS OUR INITIAL AND FINAL REPORT. ADDITIONAL COMMENTS: THE CUSTOMER EXPERIENCE REPORT SUBMITTED TO APPLIED MEDICAL MADE NO REFERENCE TO PT INJURY OR REQUIRED INTERVENTION. FOLLOW UP WITH THE HOSPITAL CONFIRMED THERE WAS INTERVENTION TO ENSURE RECOVERY OF ANY PIECES OF THE DEVICE; HOWEVER, THERE WAS NO PT INJURY.

    Description of Event or Problem · 1

    ROBOTIC HYSTERECTOMY- "TROCAR CRACKED AND BROKE ON THE SIDE UNABLE TO KEEP PNEUMO PERITONEUM, 2 PIECES WERE BROKEN OFF AND FOUND ON THE OUTSIDE OF THE PTS ABDOMEN. TWO SEPARATE CRACKS STARTED NEAR THE SEAL HOUSING AND CONTINUED DOWN THE TROCAR. ONE OF THE CRACKS HAD A PIECE (AND COVERED 8 THREADS) BREAK OFF THAT WAS "CRESCENT SHAPED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12X150MM KII SHIELDED BLADED ACCESS SYS THREADED NONE GCJ APPLIED MEDICAL C0R69 1118989

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DA VINCI ROBOT CAMERA