BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 15557179 · Received October 6, 2022

    Report

    Report Number
    2955842-2022-14435
    Event Type
    Injury
    Date Received
    October 6, 2022
    Date of Event
    June 14, 2022
    Report Date
    September 6, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119785
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PROGRASP FORCEPS INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION REPLICATED /CONFIRMED THE CUSTOMER REPORTED COMPLAINT. FA FOUND THE PRIMARY FAILURE OF BROKEN GRIP CABLE TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE PROGRASP FORCEPS INSTRUMENT WAS FOUND TO HAVE A BROKEN GRIP CABLE AT THE DISTAL END. THE ROOT CAUSE OF THE BROKEN INSTRUMENT GRIP CABLES AT DISTAL IS ATTRIBUTED TO A COMPONENT FAILURE. ADDITIONAL OBSERVATIONS NOT REPORTED BY THE SITE WERE ALSO IDENTIFIED: SIGNS OF CORROSION WERE FOUND ON THE PROGRASP FORCEPS INSTRUMENT BEARINGS. GRIP INPUT DISK BEARINGS EXHIBITED ORANGE DISCOLORATION. THE ROOT CAUSE OF THE CORRODED INSTRUMENT BEARINGS IS TYPICALLY ATTRIBUTED TO MISHANDLING/MISUSE, MOST COMMONLY CAUSED BY IMPROPER CLEANING/ REPROCESSING TECHNIQUES. THE INSTRUMENT WAS FOUND TO HAVE CORROSION ON ONE OR MORE CLAMPING PULLEYS IN THE BACKEND. THE ROOT CAUSE OF THE CORRODED INSTRUMENT CLAMPING PULLEYS IS TYPICALLY ATTRIBUTED TO MISHANDLING/MISUSE, MOST COMMONLY CAUSED BY IMPROPER CLEANING/REPROCESSING TECHNIQUE. NO IMAGE OR VIDEO WAS AVAILABLE FOR REVIEW. A REVIEW OF THE INSTRUMENT LOG FOR THE PROGRASP FORCEPS INSTRUMENT (PART NUMBER 471093-11 /LOT NUMBER K110719-0187) ASSOCIATED WITH THIS EVENT WAS PERFORMED. PER REVIEW OF THE LOGS, THE PROGRASP FORCEPS INSTRUMENT WAS LAST USED IN A PROCEDURE ON (B)(6) 2022 VIA SYSTEM (B)(4). THE ALLEGED INSTRUMENT HAD 0 USES REMAINING AFTER LAST USE. THIS COMPLAINT IS CONSIDERED A REPORTABLE MALFUNCTION AND ADVERSE EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE PROGRASP FORCEPS INSTRUMENT SPRING/CLIP WAS DISLODGING FROM THE TIP OF THE DEVICE AND FELL INSIDE THE PATIENT DURING PROCEDURE. THE SPRING/CLIP WAS RETRIEVED DURING THE SAME PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UMBILICAL HERNIA SURGICAL PROCEDURE, THE PROGRASP FORCEPS INSTRUMENT SPRING/CLIP WAS DISLODGING FROM THE TIP OF THE DEVICE CAUSING IT TO MALFUNCTION. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. THE PROGRASP FORCEPS IS A MULTIPLE-USE ENDOSCOPIC INSTRUMENT WITH A GRASPING TIP TO BE USED IN CONJUNCTION WITH THE DA VINCI SYSTEM. THE INSTRUMENT IS DESIGNED TO GRAB, MANIPULATE, RETRACT, AND DISSECT TISSUE DURING A DA VINCI ASSISTED SURGICAL PROCEDURE. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2507583 ENDOWRIST PROGRASP FORCEPS NAY INTUITIVE SURGICAL, INC 471093-11 K11210719 0187 00886874119785

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DA VINCI INSTRUMENTS AND ACCESSORIES.