MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE; HANDHELD CAMERA HEAD

Model Number	470035-03
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical inc.(isi) received the handheld camera for failure analysis investigation.The instrument was analyzed and was found to have a broken cable connector.2 out of the 4 legs of the connector were broken off.As a result of the damage, the adaptor was also found to be broken and the light guide adapter was completely dislodged from the connector.The light guide adapter was returned with the camera.Due to the damage, the qap (quality assurance procedure) could not be performed on the in-house system.Functional tests were not performed.A review of logs showed no errors found with 10 days of rma create date.Additional observation(s) related to customer complaint: the camera was found to have a detached fragment.The detached fragment was the result of the broken cable connector.The missing piece was returned with the instrument.Additional observation(s) not reported by site: the camera was found to have delamination.The distal bend protection was found delaminated from the camera housing.The camera was found to have cosmetic damage on the camera housing.Both sides of the camera housing was found to have no labeling.As a result the label markings were illegible.The complaint was confirmed by failure analysis.The probable root cause is attributed to improper cleaning or sterilization techniques used in reprocessing that can result in damage.Applying excessive pressure while wiping down the fingers to clean the moisture or any residue can cause damage to the connector pad.Additionally, damage at the endoscope controller (ec) can also be transferred to the fingers when a damaged ec is connected to the connector, causing the fingers to bend.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the instrument; however, failure analysis is still ongoing.Additional information is being gathered to determine the contribution of the device to the customer reported issue.
Event or Problem Description
It was reported that during central processing, a piece of the handheld camera broke off.There was no report of patient involvement or patient injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the customer did not have further information but was in possession of the dislodged piece.

• Brand Name: NONE
• Common Device Name: HANDHELD CAMERA HEAD
• 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: 24750916
• Report Number: 2955842-2026-20005
• Device Sequence Number: 10285698
• Product Code: GCJ
• UDI-Device Identifier: 00886874115725
• UDI-Public: (01)00886874115725
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K191043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2026

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: 470035-03
• Device Catalogue Number: 470035
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/11/2026
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 04/24/2026
• 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: Initial
• 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