BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOPOLAR CURVED SCISSOR INSTRUMENT

    MDR report key: 3770654 · Received April 24, 2014

    Report

    Report Number
    2955842-2014-02532
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    April 13, 2012
    Report Date
    March 26, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE POST-OPERATIVE COMPLICATION(S) EXPERIENCED BY THE PATIENT. THE OPERATIVE REPORT FOR THE DA VINCI HYSTERECTOMY PROCEDURE DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. THE OPERATIVE REPORT ALSO DOES NOT MENTION ARCING OR SPARKING OF AN INSTRUMENT ALTHOUGH THE SURGEON INDICATED IN THE DISCHARGE SUMMARY THAT THERE WAS AN EQUIPMENT MALFUNCTION WITH SPARKING MONOPOLAR SCISSORS. IT IS UNKNOWN WHAT THE STATUS AND LOT IS FOR THE MONOPOLAR CURVED SCISSORS INSTRUMENT INVOLVED WITH THIS COMPLAINT. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. NO ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT EXPERIENCED POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING A DA VINCI SI SURGICAL PROCEDURE. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S BLADDER INJURIES IS UNKNOWN.

    Description of Event or Problem · 1

    AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE FOR UTERINE FIBROIDS ON (B)(6) 2012. THE PLAINTIFF'S ATTORNEY ALLEGES THAT A BLADDER INJURY OCCURRED AS A RESULT OF AN ELECTROSURGICAL ISSUE. ISI WAS PROVIDED WITH THE DA VINCI OPERATIVE REPORT AND SUBSEQUENT MEDICAL RECORDS. A CAREFUL REVIEW OF THE MEDICAL DOCUMENTATION WAS CONDUCTED. THE UTERUS WAS QUITE LARGE MEASURING 667 GRAMS AND REQUIRED MORCELLATION FOR REMOVAL. THERE WERE NO INTRA-OPERATIVE COMPLICATIONS REPORTED IN THE SURGEON'S OPERATIVE REPORT. THE DISCHARGE SUMMARY HOWEVER CONTAINS THE FOLLOWING LANGUAGE: THIS WAS PERFORMED ROBOTICALLY WITH THE ONLY APPARENT COMPLICATION AT THE TIME TO BE EQUIPMENT MALFUNCTION WITH SPARKING MONOPOLAR SCISSORS. ON (B)(6) 2012, THE PATIENT HAD REPORTED COMPLAINTS OF ABDOMINAL DISCOMFORT AND FEVERS. A CT CYSTOGRAM WAS PERFORMED AND INTRAPERITONEAL EXTRAVASATION OF CONTRAST DYE FROM HER BLADDER WAS REVEALED. THE PATIENT RETURNED TO THE OR WHERE A CYSTOSCOPY WAS PERFORMED. ACCORDING TO THE OPERATIVE REPORT, A 1 CM AREA OF WHITE TISSUE DISTRIBUTED IN A LINEAR FASHION WITHIN THE RIGHT POSTERIOR BLADDER WAS FOUND. THE SURGEON NOTED THAT THE AREA APPEARED TO BE MOST CONSISTENT WITH A THERMAL INJURY AND WAS LIKELY THE SITE OF HER CYSTOTOMY. THE PATIENT THEN UNDERWENT AN EXPLORATORY LAPAROTOMY. A 3 MM AND A 5 MM CYSTOTOMY SITE WERE IDENTIFIED, EXCISED AND REPAIRED. STENT PLACEMENT WAS PERFORMED ON BOTH URETERS. SHE WAS DISCHARGED ON (B)(6) 2012. ON (B)(6) 2014, ISI CONTACTED THE RISK MANAGER AT THE SITE. SHE INDICATED THAT ACCORDING TO THE OR DIRECTOR'S REPORT FROM (B)(6) 2012, THERE WAS A REPORT OF INSTRUMENT ARCING DURING SURGERY. THE INSTRUMENT WAS EXCHANGED FOR A NEW ONE WHEN THE ARCING WAS IDENTIFIED. THE INSTRUMENT WAS PULLED FROM SERVICE AND SENT TO INTUITIVE FOR ROOT CAUSE ANALYSIS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248456 MONOPOLAR CURVED SCISSOR INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R