BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 15899513 · Received December 1, 2022

    Report

    Report Number
    2955842-2022-15688
    Event Type
    Injury
    Date Received
    December 1, 2022
    Date of Event
    October 17, 2022
    Report Date
    November 1, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119808
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSES OF THE OPERATIVE COMPLICATION CANNOT BE DETERMINED. INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE INSTRUMENT INVOLVED WITH THIS EVENT FOR FAILURE ANALYSIS EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. A SYSTEM LOG REVIEW WAS PERFORMED FOR THIS PROCEDURE: NO RELEVANT ERRORS WERE OBSERVED DURING THIS PROCEDURE. THE TWO ENERGY INSTRUMENTS USED DURING THE CASE WERE: FENESTRATED BIPOLAR FORCEPS (PART #471205-17; LOT #K12220221-0016) AND MONOPOLAR CURVED SCISSORS (PART #470179-19; LOT #K12220704-0156). NO IMAGE OR VIDEO CLIPS FOR THE REPORTED EVENT WERE SUBMITTED BY THE CUSTOMER FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER COMPLETION OF A DA VINCI-ASSISTED BILATERAL INGUINAL HERNIA PROCEDURE, IT WAS NOTED THAT THE PATIENT HAD A DEHISCED TROCAR SITE. THE SURGEON BELIEVES THE ISSUE MAY HAVE OCCURRED AFTER A POTENTIAL ARCING EVENT. IT IS UNKNOWN WHAT MEDICAL INTERVENTION WAS RENDERED DUE TO THE DEHISCED TROCAR SITE. ADDITIONALLY, ON AN UNSPECIFIED DATE POST-OPERATIVELY, THE PATIENT PRESENTED WITH A SURGICAL SITE INFECTION. THE PATIENT RECEIVED UNSPECIFIED TREATMENT FOR INFECTION. THE CAUSES OF THE OPERATIVE COMPLICATION IS UNKNOWN. IT IS ALSO UNCLEAR WHICH SPECIFIC INSTRUMENT MAY HAVE ALLEGEDLY ARCED. NOTE: REFER TO MEDWATCH REPORT (MDR) WITH PATIENT IDENTIFIER (B)(6) FOR MDR SUBMISSION OF THE EVENT REPORTED AGAINST THE MONOPOLAR CURVED SCISSORS INSTRUMENT.

    Additional Manufacturer Narrative · 0

    SECTION G3: CORRECTED TO 10/17/2022 UPON A ROUTINE RECORD REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI-ASSISTED BILATERAL INGUINAL HERNIA PROCEDURE, IT WAS NOTED THAT THE PATIENT HAD A DEHISCED TROCAR SITE. IT IS UNCLEAR WHAT MEDICAL INTERVENTION WAS RENDERED DUE TO THE DEHISCED TROCAR SITE. THE SURGEON BELIEVES THE COMPLICATION MAY HAVE OCCURRED AFTER A POTENTIAL ARCING EVENT. THE SURGEON DID NOT NOTICE ANY ARCING, SPARKING, OR LIGHT INTRAOPERATIVELY. THE PATIENT POST-OPERATIVELY PRESENTED WITH A SURGICAL SITE INFECTION. THE PATIENT RECEIVED UNSPECIFIED TREATMENT FOR THE INFECTION.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1729937 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471205-17 K12220221 0016 00886874119808

    Patients

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