BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8 MM MCS TIP COVER ACCESSORY

    MDR report key: 2781665 · Received October 10, 2012

    Report

    Report Number
    2955842-2012-00526
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    August 7, 2012
    Report Date
    September 10, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K112263
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE TIP COVER ACCESSORY NOR THE MONOPOLAR CURVED SCISSORS HAVE BEEN RETURNED FOR EVALUATION, THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. THE ROOT CAUSE OF THE SURGICAL COMPLICATION EXPERIENCED BY THE PATIENT IS ALSO CURRENTLY UNDETERMINED. ON (B)(6) 2012 THE INITIAL REPORTER INDICATED THAT THE PHYSICIAN INVOLVED WITH THIS INCIDENT HAD MADE THE DETERMINATION THAT ARCING HAD CAUSED THE DAMAGE; HOWEVER THIS DETERMINATION WAS MADE APPROXIMATELY 30 DAYS AFTER THE PROCEDURE AND AFTER THE PATIENT HAD RETURNED COMPLAINING OF PAIN. THE OPERATING ROOM STAFF AND TEAM DID NOT OBSERVE ANY ARCING DURING THE PROCEDURE AND COULD NOT CONFIRM THE PHYSICIAN'S OBSERVATION. ADDITIONALLY, SINCE THE PHYSICIAN DELAYED REPORTING THIS ARCING, THE TEAM COULD NOT ISOLATE WHICH INSTRUMENT WAS USED DURING THE CASE. ISI WAS AVAILABLE TO PROVIDE WHICH MONOPOLAR CURVED SCISSOR INSTRUMENT WAS USED DURING THAT CASE AND HAS MADE AN ATTEMPT TO HAVE THIS INSTRUMENT RETURNED. THE TIP COVER ACCESSORY USED WITH THE CASE WAS NOT SAVED AS IT IS DISPOSABLE. THE INITIAL REPORTER EXPLAINED THAT THE PHYSICIAN DID NOT HAVE MUCH EXPERIENCE AND HAD DONE ONLY A FEW OF THESE SURGERIES. THE OPERATING ROOM STAFF COULD NOT COLLABORATE THE PHYSICIAN'S STORY AND NOTHING ABNORMAL WAS OBSERVED DURING THE ORIGINAL CASE BY THE TEAM. WHILE MONOPOLAR CURVED SCISSORS TIP COVER ACCESSORY WAS DISPOSED OF AND WAS NOT AVAILABLE FOR RETURN, HOWEVER THERE WAS NOTHING ABNORMAL OBSERVED WITH THE TIP COVER DURING THE CASE EITHER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A SUCCESSFUL DA VINCI SI SACROCOLPOPEXY PROCEDURE, THE PATIENT WAS DISCHARGED ON DAY AFTER HER POSTOPERATIVE LLEUS RESOLVED. ON THE 5TH DAY THE PATIENT BEGAN EXPERIENCING ABDOMINAL PAIN AND NAUSEA. THE NEXT DAY THE PATIENT WENT IN FOR EMERGENCY CARE, WHERE SHE WAS IDENTIFIED AS HAVING A PLAIN FILM OF HER ABDOMEN SHOWING FREE AIR. A CT SCAN WAS PERFORMED OF THE ABDOMEN AND PELVIS WHICH SHOWED EXTRAVASATION OF CONTRAST FROM THE LARGE BOWEL. GENERAL SURGERY RETURNED THE PATIENT TO THE OPERATING ROOM TO EXPLORE HER ABDOMEN AND LIKELY PERFORM A COLOSTOMY. THE PATIENT REQUIRED THE MESH THAT WAS PLACED DURING THE SACROCOPLEXY TO BE REMOVED. DURING EXPLORATORY LAPAROTOMY, A 5MM PERFORATION WAS IDENTIFIED IN THE SIGMOID COLON SEVERAL CENTIMETERS DISTANT FROM THE AREA OF OPERATION. THE DEFECT IN THE COLON WAS ALLEGED TO BE CONSISTENT WITH A CAUTERY INJURY. IT IS ALLEGED THAT THIS INJURY IS LIKELY ASSOCIATED WITH ARCING/CAUTERY OF THE ROBOTIC INSTRUMENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8 MM MCS TIP COVER ACCESSORY ENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 400180

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R| S DA VINCI SI SURGICAL SYSTEM, MCS INST., ACCS., ES