BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3943733 · Received July 18, 2014

    Report

    Report Number
    2955842-2014-04384
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. THE TYPE OF SURGERY AND DATE OF THE SURGICAL PROCEDURE INVOLVED WITH THIS COMPLAINT IS UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. A RECURRENCE OF THE REPORTED FAILURE MODE RELATED TO THE INSTRUMENT'S JAWS BENDING SIDEWAYS IS NOT EXPECTED TO BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH, SERIOUS INJURY OR SERIOUS DETERIORATION IN THE STATE OF HEALTH OF A PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE INITIAL REPORTER OF THIS COMPLAINT INDICATED THAT A CABLE BROKE ON THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT. HOWEVER, THERE NO INDICATION THAT A PATIENT INJURY OCCURRED AS A RESULT OF THE REPORTED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SITE HAD 4 FENESTRATED BIPOLAR FORCEPS INSTRUMENTS THAT HAD CABLES BREAKING AND JAWS BENDING SIDEWAYS. ACCORDING TO THE SITE'S DIRECTOR OF OPERATIONS, THE INSTRUMENT INVOLVED WITH THIS COMPLAINT WAS DISCARDED. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE'S DIRECTOR OF OPERATIONS AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE DIRECTOR OF OPERATIONS INDICATED THAT NO PATIENTS WERE INJURED BECAUSE OF THE REPORTED ISSUE(S) WITH THE INSTRUMENTS. SHE ALSO DENIED THAT ANY INSTRUMENT FRAGMENTS FELL INTO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421325 FENESTRATED BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 470205-05

    Patients

    Seq Age Sex Outcome Treatment
    1