BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 15180644 · Received August 6, 2022

    Report

    Report Number
    2955842-2022-13356
    Event Type
    Injury
    Date Received
    August 6, 2022
    Date of Event
    July 6, 2022
    Report Date
    July 8, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GCJ
    UDI-DI
    00886874116562
    PMA / PMN Number
    K191736
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE 0 DEGREE ENDOSCOPE PLUS INVOLVED WITH THIS COMPLAINT, HOWEVER, DEVICE EVALUATION HAS NOT YET BEEN COMPLETED. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN THE RETURNED ENDOSCOPE HAS BEEN EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE INSTRUMENT LOG FOR THE 0 DEGREE ENDOSCOPE PLUS (PART#470056-05/LOT# SF1918164 ) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE 0 DEGREE ENDOSCOPE PLUS WAS LAST USED ON (B)(6) 2022 ON SYSTEM SK3204. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: ALTHOUGH THE CUSTOMER INDICATED THAT AN INJURY OCCURRED, THERE IS INSUFFICIENT INFORMATION PROVIDED TO SUGGEST THAT THE PATIENT SUSTAINED A SERIOUS INJURY. THERE IS NO INFORMATION PROVIDED TO INDICATE THAT THE INJURY WAS LIFE-THREATENING, REQUIRED MEDICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT, OR RESULTED WITH DISABILITY OR PERMANENT IMPAIRMENT. IN ADDITION, THERE IS NO INDICATION THAT THE PATIENT REQUIRED HOSPITALIZATION DUE TO THE INJURY.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: G3, G6, H2, AND H3 ANALYSIS INFORMATION CAN BE FOUND IN FIELDS H6 AND H10 D15- INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE 0 DEGREE ENDOSCOPE PLUS ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS WAS ABLE TO CONFIRM THE CUSTOMER REPORTED COMPLAINT OF A 3D ISSUE. ADDITIONAL FINDINGS NOT REPORTED BY THE SITE INCLUDE THE FOLLOWING: WHEN FUNCTIONALLY TESTED, THE ENDOSCOPE FAILED THE FOCUS TEST DUE TO OILY STAIN. THE ROOT CAUSE WAS NOT DETERMINABLE/APPLICABLE. THE CAMERA INSTRUMENT ADAPTER WAS FOUND TO HAVE BINDING. THE ROOT CAUSE IS ATTRIBUTED TO MISHANDLING/MISUSE. THE ENDOSCOPE WAS ALSO FOUND TO HAVE DISCOLORATION AT THE NOSE OF THE HOUSING. THE ROOT CAUSE COULD NOT BE ESTABLISHED. LASER MARKING (A COSMETIC DAMAGE) WAS FOUND ON THE HOUSING. THE ROOT CAUSE IS ATTRIBUTED TO MISHANDLING/MISUSE. THE ENDOSCOPE ALSO FAILED THE PAYLOAD TESTER. THE ROOT CAUSE WAS NOT DETERMINABLE/APPLICABLE. THE ENDOSCOPE COULD NOT BE REPAIRED AND HAS SINCE BEEN SCRAPPED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED OROPHARYNGECTOMY SURGICAL PROCEDURE, THERE WAS AN ISSUE WITH THE 3D VISION OF THE 0 DEGREE ENDOSCOPE PLUS. THE PROCEDURE WAS COMPLETED WITH AN UNSPECIFIED PATIENT INJURY REPORTED. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1469143 NONE ENDOSCOPE GCJ INTUITIVE SURGICAL, INC 470056-05 N/A 00886874116562

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DA VINCI INSTRUMENTS AND ACCESSORIES