BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 14445901 · Received May 19, 2022

    Report

    Report Number
    2955842-2022-11700
    Event Type
    Injury
    Date Received
    May 19, 2022
    Date of Event
    April 19, 2022
    Report Date
    April 19, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874120767
    PMA / PMN Number
    K180351
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED OR IS UNKNOWN. ISI HAS REQUESTED FOR RETURN OF THE FORCE BIPOLAR INSTRUMENT FOR FAILURE ANALYSIS INVESTIGATION. HOWEVER, AT THIS TIME THE INSTRUMENT HAS NOT BEEN RETURNED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED. INVESTIGATION REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. NO IMAGE OR VIDEO WAS PROVIDED BY THE CUSTOMER FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED UNILATERAL INGUINAL HERNIA SURGICAL PROCEDURE, PERITONEAL TISSUE GOT CAUGHT AROUND THE WRIST AREA OF THE FORCE BIPOLAR INSTRUMENT. ACCORDING TO THE SURGEON, A METAL PIECE APPEARED TO BE PULLED OUT FROM THE WRIST AREA OF THE INSTRUMENT. IN ORDER TO RETRIEVE THE FORCE BIPOLAR INSTRUMENT, THE SURGEON CUT OFF THE PERITONEAL TISSUE WITH ANOTHER INSTRUMENT. THE CAUSE OF THE CUSTOMER REPORTED FAILURE MODE IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UNILATERAL INGUINAL HERNIA PROCEDURE, A "SHARP CORNER CAME OUT OF THE WRIST JOINT" OF THE FORCE BIPOLAR INSTRUMENT AND WAS CAUGHT ON TISSUE. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: TWELVE TO FIFTEEN MINUTES INTO THE PROCEDURE, WHILE DISSECTING THE PERITONEUM WITH THE FORCE BIPOLAR INSTRUMENT IN A STANDARD GRIP MODE, PERITONEAL TISSUE GOT CAUGHT ON THE INSTRUMENT. THE SURGEON SAW A METAL PIECE FROM THE WRIST JOINT AREA OF THE INSTRUMENT WAS PULLED OUT. THEREFORE, THE SURGEON USED A MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT TO CUT THE TISSUE OFF IN ORDER TO RETRIEVE THE FORCE BIPOLAR INSTRUMENT. THE SURGEON STATED HE DID NOT PLACE ANY ADDITIONAL SUTURES SECONDARY TO THIS ISSUE. THE SURGEON CONFIRMED THE PERITONEUM WAS SUTURED AS A STANDARD SURGICAL STEP FOR THE INGUINAL HERNIA AND DID NOT PLACE ADDITIONAL SUTURES BECAUSE OF THE FORCE BIPOLAR ISSUE. THIS ISSUE DID NOT IMPACT THE PROCEDURE, AND HE SWITCHED THE INSTRUMENT WITH A BACKUP FORCE BIPOLAR INSTRUMENT. THE ORIGINAL FORCE BIPOLAR INSTRUMENT DID NOT HAVE FUNCTIONAL ISSUES AND WAS STILL ABLE TO GRAB TISSUE AND SUTURES. HOWEVER, THE SURGEON OPTED TO REPLACE THE FORCE BIPOLAR INSTRUMENT WITH A NEW FORCE BIPOLAR INSTRUMENT. THE FORCE BIPOLAR INSTRUMENT WAS INSPECTED BEFORE USE, AND THERE WERE NO ABNORMALITIES NOTED. PATIENT DEMOGRAPHIC INFORMATION WAS NOT AVAILABLE. THE SURGEON INDICATED THAT THE PERITONEUM WAS SUTURED AS A STANDARD SURGICAL STEP OF THE INGUINAL HERNIA PROCEDURE. THE SURGEON EXPLAINED THAT THE PERITONEUM WAS NOT SUTURED DUE TO THE ISSUE WITH THE FORCE BIPOLAR INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    965205 ENDOWRIST FORCE BIPOLAR NAY INTUITIVE SURGICAL, INC 471405-06 K10211004 0014 00886874120767

    Patients

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