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

Model Number	370890-05
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The 0° endoscope was returned to the original equipment manufacturer for evaluation.Failure analysis confirmed the reported problem.The endoscope was received with mechanical damage to the distal window assembly hermetic seal resulting in fluid invasion and subsequent major damage to optical components.The endoscope was received with non-readable rfid chip and was not recognized by software.The endoscope was also received with an unknown laser marking, and deep scratches to the shaft assembly.Fragments of adhesive of the distal window were missing.Verification of the event details via system logs cannot be performed at this time because there is insufficient event information.No image or video of the procedure was provided for review.A review of the site's complaint history does not reveal any additional complaints involving this product and/or this event.This complaint is considered a reportable event due to the following conclusion: failure analysis acknowledges that a fragment was missing from a portion of the device that enters the patient.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.Follow-up was attempted, but part of the patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.The product is not implantable.Information for is not available.Insufficient product information was provided in order to obtain the date of manufacture.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the 0° endoscope was found to have dark image in right eye.A backup endoscope was used and the procedure was completed with no reported injury.The da vinci si endoscope is intended to provide stereoscopic visualization of tissue and instruments when performing procedures with the da vinci system.Intuitive surgical, inc.(isi) has performed follow-up to request additional information regarding the event.However, no further details have been received as of the date of this complaint.

• 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: 13565425
• Report Number: 2955842-2022-10307
• Device Sequence Number: 5848740
• Product Code: NAY
• UDI-Device Identifier: 00886874110188
• UDI-Public: (01)00886874110188
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K081137
• 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): 01/27/2022

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: 370890-05
• Device Catalogue Number: 370890
• 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: 01/27/2022
• Initial Report FDA Received Date: 02/20/2022
• 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: Reuse
• 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: Unknown