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	12/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the customer experienced a fogging issue with the 0 degree endoscope.The procedure was completed with no reported injury.Per subsequent follow-up, the customer confirmed a spare endoscope was used to proceed with the case.No further information was provided.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the 0 degree endoscope involved with this complaint and completed the device evaluation.Failure analysis investigations confirmed the reported complaint of a fogging issue.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 root cause is attributed to mishandling/misuse.The endoscope was found to have mechanical damage to the proximal illumination fibers.Fragments of adhesive of the distal window are missing.The root cause is attributed to mishandling/misuse.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.Verification of the si endoscope product via system logs cannot be performed because si endoscope product details are not captured in the system log.No image or video was provided for review.This complaint is being reported because failure analysis acknowledges that a fragment was missing 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, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.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.
Additional Manufacturer Narrative
Corrections can be found in the following field: a3: patient gender.Additional information can be found in the following fields: a2, a3, a4, g3, g6, h2, h10.Intuitive surgical, inc.(isi) has received additional information from the customer regarding the reported event: the customer confirmed that the missing fragments from the endoscope occurred outside of the surgical procedure.There was no report of fragments falling from the device while used within a patient.The patient did not experience any post-surgical complications.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• 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: 13715007
• Report Number: 2955842-2022-10554
• Device Sequence Number: 6363209
• Product Code: NAY
• UDI-Device Identifier: 00886874110188
• UDI-Public: (01)00886874110188
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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,Followup
• 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
• Supplement Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 03/09/2022
• Supplement Report FDA Received Date: 04/29/2022
• 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 Age: 56 YR
• Patient Sex: Male
• Patient Weight: 95 KG