BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PK DISSECTING FORCEPS

    MDR report key: 7278877 · Received February 16, 2018

    Report

    Report Number
    2955842-2018-10004
    Event Type
    Injury
    Date Received
    February 16, 2018
    Date of Event
    December 13, 2017
    Report Date
    January 25, 2018
    Manufacturer
    INTUITIVE SURGICAL INC
    Product Code
    NAY
    PMA / PMN Number
    K061260
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED OR IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, IT WAS ALLEGED THAT A WIRE WAS FOUND IN THE SURGICAL SITE. AT THIS TIME THE FOLLOWING INFORMATION IS UNKNOWN: THE LOCATION OF THE INSTRUMENT FRAGMENT AND IF THE BROKEN PIECE WAS RETAINED INSIDE THE PATIENT.

    Description of Event or Problem · 1

    ON 02/09/2018 INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY REPORT # MW5074145 WITH THE FOLLOWING EVENT DESCRIPTION: "PERFORMING HYSTERECTOMY ROBOTIC SURGERY, AT CONCLUSION OF SURGERY WIRE WAS FOUND IN SURGICAL SITE. SUSPECTED FROM ROBOTIC INSTRUMENT." THE FOLLOWING INSTRUMENTS WERE REPORTED UNDER THIS MEDWATCH: MONOPOLAR CURVED SCISSORS (420179), PK DISSECTING FORCEPS (420227), MEGA NEEDLE DRIVER (420194), AND PROGRASP (420093). HOWEVER THERE WAS NO SITE, SYSTEM OR LOT AND SEQUENCE NUMBERS FOR THE INSTRUMENTS REPORTED IN THE MEDWATCH. ISI CONTACTED FDA; HOWEVER, THEY WERE UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION. IT IS UNKNOWN AS TO WHICH INSTRUMENT THE "WIRE WAS FOUND IN SURGICAL SITE" REPORTED IN THIS MEDWATCH CORRESPONDS TO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119719 PK DISSECTING FORCEPS ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL INC 420227

    Patients

    Seq Age Sex Outcome Treatment
    1 Other