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

Model Number	370890-05
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	12/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The 0° endoscope was returned for evaluation.Failure analysis confirmed the reported complaint.The endoscope received with mechanical damage to the distal window assembly hermetic seal resulting in fluid invasion and subsequent major damage to optical components.Fragments of adhesive of the distal window are missing.The root cause was attributed to mishandling/misuse.A review of the site's complaint history does not reveal any additional complaints involving this product and/or this event.No image or procedure vide was provided for review.No system log information was available for review.This complaint is being reported 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.Blank mdr fields: follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.Not applicable because the product is not implantable.The information for blank fields is not available.Fields are not applicable.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, blurry vision in one eye on the 0° endoscope occurred.A backup endoscope was used and the procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the customer and obtained the following additional information.The problem with endoscope was detected in the stages of preparation for surgery and scope calibration.A backup endoscope was unpacked immediately and used from beginning of surgery.The customer reported there is no concern that the missing fragment has reached the patient.The customer stated the damage occurred during transfer, or cleaning in the sterile processing department.

• 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: 13706898
• Report Number: 2955842-2022-10548
• Device Sequence Number: 5332568
• Product Code: NAY
• UDI-Device Identifier: 00886874110188
• UDI-Public: (01)00886874110188
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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): 02/09/2022

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: 01/14/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 03/09/2022
• 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