BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 16873743 · Received May 4, 2023

    Report

    Report Number
    2955842-2023-12386
    Event Type
    Injury
    Date Received
    May 4, 2023
    Date of Event
    April 4, 2023
    Report Date
    April 4, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112298
    PMA / PMN Number
    K220023
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE MONOPOLAR CURVED SCISSORS (MCS) IGNITING AND RESULTING IN CHARRING WAS NOT YET DETERMINED. THE MCS INSTRUMENT WAS RECEIVED BUT EVALUATION HAS NOT BEEN COMPLETED. REVIEWS OF THE SYSTEM LOG AND THE INSTRUMENT LOG WERE COMPLETED, AND NO RELATED SYSTEM ERRORS WERE OBSERVED. A REVIEW OF THE PROVIDED IMAGE WAS PERFORMED BY AN ISI CLINICAL DEVELOPMENT ENGINEER (CDE). THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: ¿FROM REVIEWING THE IMAGES I CAN CONFIRM THAT THE SITE USED AN ERBE GENERATOR, THE MONOPOLAR CURVED SCISSORS INSTRUMENT HAS HALF OF ITS TIP COVER MISSING, WHICH WAS BURNT, THE THIRD-PARTY 5MM TROCAR IS SEVERELY DEFORMED, AND THE STAINLESS-STEEL CANNULA HAS BURN MARKS AT ITS TIP.¿ INTUITIVE SURGICAL, INC RECEIVED A VIDEO CLIP RELATED TO THE COMPLAINT. A REVIEW OF THE VIDEO CLIP WAS CONDUCTED BY A CLINICAL DEVELOPMENT ENGINEER. THE FOLLOWING INFORMATION WAS PROVIDED: IT DOES NOT SEEM LIKE THERE WAS AN ARC OR INSTRUMENT-INSTRUMENT CONTACT/VICINITY TRIGGERING AN ARC, HOWEVER, IT IS POSSIBLE THAT THE MONOPOLAR CURVED SCISSORS BLADES HAD SOME CARBONIZED TISSUE THAT TRIGGERED THE IGNITION. REVIEW OF THE EVENT WAS COMPLETED BY AN ISI MEDICAL SAFETY OFFICER (MSO) WHO CONCLUDED THAT ACCORDING TO THE INFORMATION IN THE SUMMARY OF EVENTS, DURING THE PROCEDURE, THE MCS IGNITED AND CAUGHT FIRE CAUSING MODERATE DAMAGE TO DA VINCI AND 3RD PARTY PORTS AND RESULTED IN FRAGMENTS FALLING INTO THE PATIENT. MOST OF THE FRAGMENTS WERE RETRIEVED. THE DAMAGE TO THE SURROUNDING TISSUE WAS MINOR AND NO REPAIR OR EXCISION OF ANY ORGANS OR TISSUE WAS REQUIRED. NO LONG-TERM UNTOWARD EFFECTS TO THE PATIENT HAVE BEEN NOTED TO DATE. BASED ON THE INFORMATION PROVIDED IN THE SUMMARY OF EVENTS, THE SITUATION AND EVENT LED DIRECTLY TO THE ADVERSE EVENTS AS DESCRIBE ABOVE. THIS COMPLAINT IS CONSIDERED A REPORTABLE ADVERSE EVENT AND MALFUNCTION DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) IGNITED ONE HOUR INTO THE PROCEDURE WHILE INSIDE THE PATIENT ANATOMY RESULTING IN CHARRED AREAS OF THE PERITONEUM AND ABDOMINAL MUSCLE, AND A BURN MARK AT ONE PORT INCISION.

    Additional Manufacturer Narrative · 0

    ON 11-MAY-2023, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED ABOUT THE REPORTED EVENT: THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT AND THE MCS TIP COVER ACCESSORY HAVE BEEN RECEIVED AND INVESTIGATIONS COMPLETED. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE THERMAL DAMAGE ON THE INSTRUMENT TIPS. THE INSTRUMENT WAS RETURNED WITH THE TIP COVER STILL ATTACHED. THE INSTRUMENT PASSED ELECTRICAL CONTINUITY. THE ROOT CAUSE OF THIS FAILURE IS ATTRIBUTED TO MISHANDLING/MISUSE. ADDITIONALLY, THE INSTRUMENT¿S DISTAL END WAS OBSERVED TO HAVE MELTED RESIDUE FROM THE TIP COVER INSTALLED, LIKELY DUE TO THE THERMAL DAMAGE EXPERIENCED. THERE WAS RESIDUE FOUND ON THE DISTAL CLEVIS, DISTAL PULLEYS, AND GRIP CABLES. THE ROOT CAUSE OF THIS IS NOT ESTABLISHED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED COMPONENT SEPARATION ETEP (EXTENDED TOTAL EXTRAPERITONEAL) HERNIA REPAIR, THE PATIENT EXPERIENCED BURN INJURIES WHEN THE MONOPOLAR CURVED SCISSORS (MCS) IGNITED ALMOST ONE HOUR INTO THE PROCEDURE. THE INTUITIVE SR. CLINICAL SALES EXECUTIVE RECEIVED INFORMATION FROM THE SURGEON ALLEGING THAT THE EVENT OCCURRED INSIDE THE PATIENT ANATOMY DURING DIVISION OF THE TRANSVERSUS ABDOMINIS, DAMAGING THE MCS INSTRUMENT, MCS TIP COVER, ONE OF THREE DA VINCI CANNULAS, AND A THIRD-PARTY ETHICON XCEL 5MM PLASTIC CANNULA. AT THE TIME OF THE EVENT, THE MCS INSTRUMENT WAS INSERTED INTO A SINGLE-CANNULATED DA VINCI CANNULA WHICH WAS APPROXIMATELY 8-10CM AWAY FROM THE XCEL CANNULA. WHILE DISSECTING AND CAUTERIZING, UPON ACTIVATION OF MONOPOLAR COAGULATION, A SMALL ¿SPARKLE¿ (ARCING) APPEARED BETWEEN THE MCS INSTRUMENT JAWS WHILE IN CONTACT WITH ABDOMINAL WALL MUSCLE. THE MCS TIP COVER IGNITED AT THE PROXIMAL PORTION, AND THE TIP COVER COMPLETELY BURNED, AND THE FRAGMENTS SPILLED INTO THE ABDOMEN. THE MCS JAWS AND PART OF THE WRIST WERE ALSO BURNED. THE PLASTIC XCEL CANNULA ALSO EXHIBITED SOME MELTING DAMAGE. SOME AREAS OF THE PERITONEUM AND ABDOMINAL MUSCLE WERE CHARRED, A BURN MARK WAS OBSERVED AROUND ONE PORT SITE INCISION, AND THE DA VINCI CANNULA WAS STUCK TO CHARRED TISSUE. THE SURGEON CONVERTED TO LAPAROSCOPY AND MOST OF THE FRAGMENTS WERE RETRIEVED USING LAPAROSCOPIC INSTRUMENTS AND LAVAGE; IT COULD NOT BE ASCERTAINED IF ALL OF THE FRAGMENTS WERE REMOVED. THE PROCEDURE WAS COMPLETED LAPAROSCOPICALLY. NO POST-OPERATIVE TESTS WERE PERFORMED POST PROCEDURE (E.G., X-RAY OR ULTRASOUND). THE SURGEON DID NOT EXCISE THE BURNED TISSUE AND DID NOT PROVIDE ANY TREATMENT TO THE PORT SITE BURN AT THE TIME OF THE EVENT. THE PATIENT DEVELOPED ACUTE KIDNEY INJURY POST-OPERATIVELY, WAS MANAGED IN THE ICU FOR 5 DAYS, THEN WAS DISCHARGED HOME ON POSTOPERATIVE DAY SEVEN. A STANDARD POST-DISCHARGE FOLLOW-UP OCCURRED ONE WEEK LATER WITH NO REPORT OF ANY COMPLICATIONS RECEIVED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PORT CANNULAS, MCS INSTRUMENT AND TIP COVER ACCESSORY WERE INSPECTED PRIOR TO USE; THE DEVICES WERE NEWLY OPENED FOR THE PROCEDURE AND NO ANOMALIES WERE NOTED. THE MCS TIP COVER WAS PROPERLY INSTALLED WITH THE INSTALLATION TOOL. THERE HAD BEEN NO MCS INSTRUMENT COLLISIONS WITH OTHER INSTRUMENTS. THE MCS INSTRUMENT TIPS DID NOT TOUCH ANY STAPLES, CLIPS OR SUTURES WHILE ENERGIZED. THE MCS JAWS WERE NOT IMMERSED IN LIQUID OR CONTAMINATED WITH BIO DEBRIS PRIOR TO ACTIVATION. THE MCS HAD NOT BEEN REMOVED AT ANY TIME PRIOR TO SPARKING. THE GENERATOR WAS A THIRD-PARTY ERBE AND THEIR STANDARD SETTINGS WERE USED. A SINGLE USE DISPOSABLE MEDTRONIC VALLEYLAB NEUTRAL GROUNDING PAD WAS PLACED UNDERNEATH THE PATIENT¿S HIP AND IT DID NOT APPEAR TO HAVE ANY ISSUES OR DEFECTS. A THIRD-PARTY LEXION INSUFFLATION DEVICE WAS IN USE WITH C02 BEING SUPPLIED THROUGH WALL CONNECTORS, WHICH ARE CHECKED DAILY, AND TRANSFERRED BY A ¿CENTRAL IV-LINE TUBING¿. THERE WERE NO ISSUES MAINTAINING PNEUMOPERITONEUM AND NO LEAKS DETECTED. THE LEXION SETTINGS WERE ON LAPAROSCOPIC MODE. THE PATIENT DOES NOT HAVE IMPLANTS. NO ELECTROLUBE, OTHER LUBRICATION, SOLVENT, OR ALCOHOL WIPES WERE USED ON THE INSTRUMENTS BEFORE THE ISSUE OCCURRED.

    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
    628399 ENDOWRIST MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 470179-19 K11220926 0227 00886874112298

    Patients

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