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	11/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has issued a return material authorization (rma) to have the device returned.However, isi has not received the instrument involved with the alleged issue to perform failure analysis.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 a da vinci-assisted benign hysterectomy surgical procedure, a single-port (sp) endoscope was damaged when the surgeon was rotating the instrument drives to change above/below setup while the entry guide did not rotate together with the instrument drives.There was no fragment falling into the patient.The customer used a backup endoscope to continue with the procedure.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the nurse and obtained the following additional information: the distal part of the single-port (sp) endoscope was detached.It was confirmed that the fragment fell outside of the patient¿s body.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical inc.(isi) received the endoscope firefly for failure analysis investigation.The unit was analyzed and found to have shaft mechanical damage.The distal main tube was found to be bent inward.Despite the damage on the distal main tube, the endoscope was still fully functional.Although the mechanical shaft was damaged, the qap (quality assurance procedure) could still be performed on the in-house system.Functional tests were performed and passed.Stereo calibration, endoscope focus test and color recognition was performed and passed.Images were clear, dewarped and not grainy.Noise or motion blur was seen.The buttons was fully functional and moved intuitively.First edt testing passed.A review of logs showed q 1 of error 282 (tool invalid reason).Leak tests were performed and passed.The endoscope was also found to have a detached fragment near the proximal end.The camera was found with a broken detached fragment from the chassis, measuring 1.77 in x 0.59 in.The fragment was detached and returned with the endoscope.The complaint was confirmed by failure analysis.The probable root cause is attributed to damage during use or improper handling, which may include accidental drops of the endoscope or inadvertent collisions with hard surfaces.

• 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: 23709913
• Report Number: 2955842-2025-47193
• Device Sequence Number: 10641938
• Product Code: IZI
• UDI-Device Identifier: 00886874122228
• UDI-Public: (01)00886874122228(11)250829
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Report Date (Section B): 12/22/2025

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: 11/21/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2025
• 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: Female