BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 19210761 · Received April 30, 2024

    Report

    Report Number
    2955842-2024-14009
    Event Type
    Malfunction
    Date Received
    April 30, 2024
    Date of Event
    April 2, 2024
    Report Date
    April 4, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112441
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE 8MM SMALL GRASPING RETRACTOR INSTRUMENT AND COMPLETED THE DEVICE EVALUATION. THE INSTRUMENT WAS ANALYZED AND IT WAS FOUND THAT IT HAS A BROKEN PITCH CABLE AT THE PROXIMAL CLEVIS HOLE. THE BROKEN CABLE SEGMENT THAT CONTAINS THE CRIMP WAS MISSING FROM THE CLEVIS. THE CABLE WAS FULLY BROKEN. THERE WAS NOT EVIDENCE OF DISCOLORATION OR CORROSION/CONTAMINATION ON THE CABLES TO INDICATE A REPROCESSING INDUCED ISSUE. THE COMPONENTS SURROUNDING THE BROKEN CABLE DID NOT EXHIBIT ABNORMAL SHARP EDGES OR DAMAGE THAT WOULD HAVE CONTRIBUTED TO THE CABLE BREAKING..

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY SURGICAL PROCEDURE, THE 8MM SMALL GRASPING RETRACTOR INSTRUMENT HAD A BROKEN WIRE. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE EVENT DATE WAS CLARIFIED AS (B)(6) 2024. THE REPORTER FILLED OUT THE INFORMATION ON THE DA VINCI PAPERWORK TO THE BEST OF THEIR KNOWLEDGE AND STATED THAT THE DOCTOR MAY HAVE MORE INSIGHT TO THE WIRE BEING BROKEN. THE SITE DISCLOSED THE PATIENT DEMOGRAPHICS. DEMOGRAPHICS: A. AGE AND UNIT (YEARS/MONTHS/DAYS): 44 YEARS OLD. B. DATE OF BIRTH: 6/21/1979. C. GENDER: MALE. D. WEIGHT AND UNIT (LBS/KGS): 227 LBS/ 103 KGS. E. BODY MASS INDEX (BMI): 32 BMI. F. HEIGHT AND UNIT (CM/INCHES): 177.8 CM (5FT 10 IN). G. ETHNICITY: NOT HISPANIC OR LATINO ORIGIN. H. RACE: WHITE/CAUCASIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2080501 ENDOWRIST SMALL GRASPING RETRACTOR NAY INTUITIVE SURGICAL, INC 470318-10 K10231012 0139 00886874112441

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES