MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI; ENDOSCOPE

Model Number	370893-03
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The endoscope involved with this complaint was received and device evaluation was completed.Failure analysis confirmed the initial complaint that the endoscope appeared to have a dark and cloudy image.The endoscope was received with mechanical damage to the distal window assembly hermetic seal resulting in fluid invasion and subsequent major damage optical components.Fragments of adhesive of the distal window were missing.Verification of the event details cannot be performed via system logs because system logs were not available at this time.A review of the site's complaint history revealed no additional complaints related to this product.This complaint is being reported because failure analysis investigation identified a missing fragment from a portion of the device that enters the patient (distal end).While there was no harm or injury to patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.
Event or Problem Description
It was reported that prior to starting (pre anesthesia) a da vinci assisted prostatectomy surgical procedure, the endoscope appeared to have a dark and cloudy image.The procedure was completed with a spare endoscope, with no report of patient harm, adverse outcome or injury.

• Brand Name: DA VINCI
• Common Device Name: ENDOSCOPE
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 13596593
• Report Number: 2955842-2022-10352
• Device Sequence Number: 5833872
• Product Code: NAY
• UDI-Device Identifier: 00886874110218
• UDI-Public: (01)00886874110218
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K101077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 370893-03
• Device Catalogue Number: 370893
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2022
• Initial Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Male