BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI

    MDR report key: 15481454 · Received September 24, 2022

    Report

    Report Number
    2955842-2022-14186
    Event Type
    Injury
    Date Received
    September 24, 2022
    Date of Event
    August 25, 2022
    Report Date
    August 25, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K112263
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE REPORTED INCIDENT IS UNKNOWN. IT WAS CONFIRMED THAT THE MCS TIP COVER ACCESSORY WAS DISCARDED. THE MCS AND PROGRASP FORCEPS INSTRUMENTS HAVE NOT BEEN RETURNED TO ISI FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP MDR WILL BE SUBMITTED THE SITE'S SYSTEM LOGS WERE REVIEWED FOR THE REPORTED PROCEDURE DATE. INVESTIGATION REVEALED NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. THE MCS AND PROGRASP FORCEPS INSTRUMENT HAVE NOT BEEN USED IN SUBSEQUENT PROCEDURES. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED PARASTOMAL HERNIA REPAIR, THE SURGEON WITNESSED SMOKE WHILE TAKING DOWN ADHESIONS WITH A MCS INSTRUMENT AND PROGRASP FORCEPS INSTRUMENT. HOWEVER, THE SURGEON REPORTEDLY DID NOT OBSERVE ARCING OF ELECTRICAL ENERGY DURING THE EVENT. AT THAT TIME, THE SURGEON IDENTIFIED CHARRED VISCERAL TISSUE ON THE BASE OF THE ABDOMEN. NO MEDICAL INTERVENTION WAS RENDERED INTRA-OPERATIVELY TO THE PATIENT AS A RESULT OF THE CHARRED TISSUE. HOWEVER, ON POD #6, THE PATIENT UNDERWENT A SECOND PROCEDURE TO REPAIR A BOWEL INJURY ON THE LARGE INTESTINE. THE CAUSE OF THE POST-OPERATIVE BOWEL INJURY IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARASTOMAL HERNIA REPAIR, THE SURGEON WAS USING A MONOPOLAR CURVED SCISSOR (MCS) INSTRUMENT AND POTENTIAL ARCING OCCURRED AGAINST A PROGRASP FORCEPS INSTRUMENT. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE SURGEON STATED HE WAS TAKING DOWN ADHESIONS WITH THE MCS AND THE PROGRASP FORCEPS INSTRUMENTS. THE SURGEON INDICATED THAT HE DID NOT WITNESS ARCING FROM THE MCS INSTRUMENT; HOWEVER, HE SAW SMOKE. THERE WAS CHARRED TISSUE ON THE BASE OF THE ABDOMEN ON VISCERAL TISSUE NEAR THE PROGRASP FORCEPS INSTRUMENT. UPON EXAMINATION, HE DID NOT NOTICE ANY HOLES IN THE TISSUE AND HENCE DID NOT WARRANT ANY REPAIR. THE SURGEON ASKED FOR THE PROGRASP FORCEPS INSTRUMENT TO BE SWAPPED, AND NO ISSUE WAS REPORTED AFTERWARDS. THE SURGEON CONFIRMED NO FRAGMENTS FELL INSIDE THE PATIENT FROM THE PROGRASP FORCEPS INSTRUMENT. ON POST-OPERATIVE DAY (POD) #6, THE PATIENT UNDERWENT A SECOND OPEN PROCEDURE FOR UNSPECIFIED SYMPTOMS. THE PATIENT WAS IDENTIFIED WITH A BOWEL INJURY ON THE LARGE INTESTINE, RIGHT BELOW THE CANNULA INSTALLATION (INFERIOR LEFT) WHERE THE PROGRASP FORCEPS INSTRUMENT WAS INSTALLED. THE COLON WAS REPAIRED WITH A PARTIAL RESECTION. THE PATIENT WAS IN THE ICU AND STILL RECOVERING. IT WAS CONFIRMED THAT THE MCS TIP COVER ACCESSORY INSTALLED ON THE MCS INSTRUMENT HAD BEEN DISCARDED. ISI ATTEMPTED TO CONTACT THE SURGEON FOR ADDITIONAL INFORMATION; HOWEVER, THE SURGEON WAS UNWILLING TO PROVIDE ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2545620 DA VINCI TIP COVER ACCESSORY NAY INTUITIVE SURGICAL, INC 400180-14 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES.