BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 3973403 · Received August 1, 2014

    Report

    Report Number
    2955842-2014-04660
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    January 14, 2014
    Report Date
    January 14, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE INTRA-OPERATIVE INJURY SUSTAINED BY THE PATIENT IS UNKNOWN. HOWEVER,IT HAS BEEN DETERMINED THAT THE SURGEON'S USE OF THE PROGRASP FORCEPS INSTRUMENT TO MOBILIZE THE PATIENT'S BOWEL LIKELY CONTRIBUTED TO THE DAMAGE TO THE PATIENT'S COLON. ISI HAS CONTACTED THE HOSPITAL'S RISK MANAGEMENT DEPARTMENT TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED INCIDENT. AS OF THE DATE OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. A FOLLOW-UP MDR WILL BE SUBMITTED AFTER THE EVALUATION HAS BEEN COMPLETED OR IF ADDITIONAL INFORMATION IS RECEIVED. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE INJURY SUSTAINED BY THE PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI INGUINAL HERNIA REPAIR PROCEDURE, THE PATIENT SUSTAINED A BOWEL INJURY; AS A RESULT THE PLANNED SURGERY WAS CONVERTED TO OPEN SURGICAL TECHNIQUES TO REPAIR THE DEFECT. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE THAT CAUSED OR CONTRIBUTED TO THE INJURY SUSTAINED BY THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI INGUINAL HERNIA REPAIR PROCEDURE, WHILE MOBILIZING THE PATIENT'S BOWEL USING THE PROGRASP FORCEPS INSTRUMENT, THE PATIENT'S BOWEL WAS PERFORATED. ACCORDING TO THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) WHO WAS PRESENT DURING THE SURGICAL PROCEDURE, WHILE THE SURGEON WAS TRYING TO REDUCE THE PATIENT'S HERNIA, HE NOTICED THAT THE SURGEON WAS PULLING ON BOWEL THAT WAS TRAPPED IN THE HERNIA SAC WITH THE PROGRASP FORCEPS INSTRUMENT. THE CSR VERBALLY SUGGESTED TO THE SURGEON THAT HE COULD SUBSTITUTE AN ENDOWRIST BOWEL GRASPER INSTRUMENT FOR THIS TASK. THE CSR INDICATED THAT THE SURGEON INSTRUCTED A NURSE TO REMOVE THE PROGRASP INSTRUMENT AND INSTALL A BOWEL GRASPER INSTRUMENT. AFTER A FEW MINUTES OF USE, THE SURGEON EXPRESSED VERBALLY THAT THE BOWEL GRASPER INSTRUMENT WAS NOT MEETING HIS NEEDS, AS THE SURGEON INDICATED THAT HE DID NOT LIKE THE INSTRUMENT FOR THAT TASK BECAUSE IT WAS SLIPPING ON THE TISSUE. THE SURGEON INSTRUCTED THE NURSE TO REMOVE THE BOWEL GRASPER INSTRUMENT AND RE-INSTALL THE ORIGINAL PROGRASP FORCEPS INSTRUMENT. AFTER THE PROGRASP FORCEPS INSTRUMENT WAS RE-INSTALLED THE SURGEON RESUMED USING THE INSTRUMENT. THE CSR THEN OBSERVED THE SURGEON PULLING ON THE BOWEL TISSUE WITH THE PROGRASP INSTRUMENT WHEN A TEAR OCCURRED AND CONTENTS OF THE BOWEL BEGAN TO LEAK. THE CSR LEFT THE OPERATING ROOM (OR) AND INFORMED THE OR MANAGER THAT THE CASE HAD ENCOUNTERED DIFFICULTIES. THE CSR INDICATED THAT HE RETURNED SHORTLY THEREAFTER TO THE OR AND OBSERVED THAT THE SURGEON HAD CONVERTED THE PROCEDURE TO OPEN SURGICAL TECHNIQUES TO REPAIR THE DEFECT TO THE PATIENT'S BOWEL. THE DA VINCI SURGICAL SYSTEM WAS ALREADY UNDOCKED FROM THE PATIENT AND STOWED AWAY. THE CSR LEFT THE OR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450873 PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093 M10121212 817

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention