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	11/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the endoscope involved with this complaint and completed the device evaluation.Failure analysis confirmed the initial complaint that the endoscope had a fogging issue.The endoscope was received with mechanical damage to distal window assembly hermetic seal resulting in fluid invasion and damage to optical components.Fragments of adhesive of the distal window were missing.The following was found during the device evaluation, but is not related to the reportable finding: the endoscope was also received with mechanical damage to proximal illumination fibers.Verification of the event details cannot be performed via system logs because system logs do not exist for da vinci si endoscopes.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.No image or procedure video was provided for review.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).Based on the information provided, there was no report from the customer that a fragment from the instrument fell into the patient during the procedure.While there was no report of harm or injury to the patient and no report of fragments falling into the patient, the reported failure mode could likely cause or contribute to an adverse event if the fragment(s) did fall into the patient.
Event or Problem Description
It was reported that during a da vinci-assisted prostatectomy surgical procedure, there was a fogging issue.The procedure was completed with a back-up endoscope.There was no reported injury nor delay.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) obtained the following additional information from the customer about the complaint: the missing material/damage occurred outside the surgical procedure.There was no report of fragments falling from the device while used within a patient.The patient has not returned to the hospital due to experiencing any post-surgical complications related to retaining a foreign material.Due to its privacy policy the hospital doesn't provide patient demographics nor any relevant tests and patient history.

• 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: 13596111
• Report Number: 2955842-2022-10349
• Device Sequence Number: 1957358
• Product Code: NAY
• UDI-Device Identifier: 00886874110218
• UDI-Public: (01)00886874110218
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K101077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• 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: 12/16/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2022
• Supplement Date Received by Manufacturer: 01/30/2022
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 03/25/2022
• 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