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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to the start (post-anesthesia) of a da vinci-assisted surgical procedure, single-port (sp) endoscope had a ¿moving piece¿ at the tip.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 customer and obtained the following additional information: there were no fragments missing from the tip of the endoscope.No fragment did fall into the patient's anatomy.The customer used a backup endoscope to continue with the procedure.
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 endoscope 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
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 a damage endoscope shaft.The endoscope shaft had a dislodged disc/dislodged wrist disc.The damage was observed on one location of the joints of the main shaft approximately at 2.93# from the distal end.As a result of the damage, the endoscope could not be inserted into the cannula and the qap (quality assurance procedure) could not be performed.However, the endoscope passed engagement and recognition on the in-house system.No missing material was observed.Additional observations not reported by site: the camera was found with a cable frayed.The frayed cable/damage to wire rope was near the location of the dislodged wrist disc.The wire ropes were not fully broken.No missing material was observed.The camera passed air leak test and passed 1st endoscope diagnostic test (edt) testing.Video feed during tip articulation on edt test had no issue, range of motion was limited due to the dislodged wrist disc.The probable root cause of a dislodged wrist disc is typically attributed to the user.This issue can be resolved by using an alternate endoscope to complete the procedure.Intuitive surgical, inc.(isi) followed up with the customer and obtained the following additional information: there were no fragments missing from the tip of the endoscope.No fragment did fall into the patient's anatomy.The customer used a backup endoscope to continue with the procedure.

• 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: 23058656
• Report Number: 2955842-2025-37793
• Device Sequence Number: 9225692
• Product Code: NAY
• 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
• Report Date (Section B): 08/26/2025

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: 08/26/2025
• Supplement Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 10/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2025
• 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: Unknown