MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST SP; CAMERA, 0°

Model Number	430077-05
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted prostatectomy radical extraperitoneal with lymphadenectomy surgical procedure, the customer observed that the firefly was was no recognizing.The customer was sending the firefly for return material authorization.There was no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the problem was identified during the procedure.It was unknown if there was any fragment fell into the patient and if the patient was injured.The problem delayed the operation but the minutes were unknown.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has requested that the endoscope firefly be returned for failure analysis testing.As of the date of this report, the product has not yet been received.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The product was analyzed and was found to have multiple 48221, 48406, 48216, 48221, 4822 and 48229 errors during log review was confirmed from the scope error finder but was not replicated during in-house testing.The camera passed the engagement and recognition on multiple attempts on in-house system.The qap (quality assurance procedure) was performed and passed calibration and was able to recognize all different targets/images with no issue on different distances.There was no ghosting observed when switching from different targets.Both the right eye and left eye appeared to have readable good image quality.The button function to rotate the camera had no issue.Performed firefly test with no issue on the in-house system.The camera passed air leak test and passed the first edt test.The root cause is not determinable.A review of the logs showed the following errors: 48406 watchdog illuminator timeout, 48216 camera temperature sensor failure, 48221 camera communication error, 48225 camera power failure, 48229 -camera power warning.Additional observations not related to the customer reported complaint.The camera failed the second edt test due to the images being grainy or not smooth during the test.Illumination and capture image, tip articulation.The camera button pack was found to have mechanical indentation.The illuminator button and button invert had indentations/damage on the button¿s edges.The root cause is typically attributed to user.The cable connector was found to have damage on the cable light guide ferrule.Heat damage was found on ferrule.The root cause of cable connector ¿ ferrule damage is typically attributed to the user, such a improper reprocessing.The complaint was not confirmed by failure analysis.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The product was analyzed and was found to have the sign of fluid ingress was noticed on the proximal side.Mostly the fluid was on the perimeter ring with few spots on the fiber optical aperture as circled in the attached image.This is result of the leakage between the inner ferrule and the outer ferrule which the design fix is in progress.The complaint was not confirmed by failure analysis.The probable root cause cannot be determined.

• Brand Name: ENDOWRIST SP
• Common Device Name: CAMERA, 0°
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 20829031
• Report Number: 2955842-2024-22659
• Device Sequence Number: 3863124
• Product Code: IZI
• UDI-Device Identifier: 00886874122228
• UDI-Public: (01)00886874122228
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K212101
• 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,Followup
• Report Date (Section B): 11/07/2024

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: 430077-05
• Device Catalogue Number: 430077
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/07/2024
• Supplement Date Received by Manufacturer: 01/15/2025; 03/05/2025
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 02/11/2025; 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2024
• 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