MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE; ENDOSCOPE, FIREFLY

Model Number	370892-03
Medical Device Problem Code	Optical Distortion (3000)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has requested that the 0 degree endoscope be returned for evaluation, however it has not yet been received.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received.The product associated with this event is an si endoscope and does not get captured by the procedure logs.As a result, a tool usage log could not be performed to determine when the scope was last used during a procedure.No image or procedure video was provided.This complaint is being reported based on the following conclusion: the customer allegedly converted after the start of the procedure due to an issue with an 0 degree endoscope.While there was no harm or injury to the patient, system unavailability after the start of a surgical procedure could likely cause or contribute to an adverse event if it were to recur as it may lead to an injury due to the patient¿s inability to tolerate a procedure change.
Event or Problem Description
It was reported that during a da vinci assisted surgical procedure, the 0 degree endoscope showed a blurry image.For reasons unclear, the site indicated that the procedure was converted to another da vinci system.There was no reported injury.Isi made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
Based on the claim against the product by the customer noting blurry image, an investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The endoscope was analyzed and found to have mechanical damage to the distal window hermetic seal resulting in fluid invasion.The endoscope also had mechanical damage and/or deep scratches to the ocular sleeve.Fragments of adhesive of the distal window are missing.The complaint regarding blurry image was confirmed by failure analysis, which indicates that the device did contribute to the customer reported issue.

• Brand Name: NONE
• Common Device Name: ENDOSCOPE, FIREFLY
• 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: 15695389
• Report Number: 2955842-2022-14985
• Device Sequence Number: 17959945
• Product Code: GCJ
• UDI-Device Identifier: 00886874110201
• UDI-Public: (01)00886874110201
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,Followup
• Report Date (Section B): 09/30/2022

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: 370892-03
• Device Catalogue Number: 370892
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2022
• Supplement Date Received by Manufacturer: 12/09/2022
• Initial Report FDA Received Date: 10/29/2022
• Supplement Report FDA Received Date: 01/06/2023
• 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