MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; FORCE BIPOLAR

Model Number	470405-06
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after a da vinci-assisted surgical procedure, the 8 mm force bipolar instrument had a lot of "k10250409" but no failure was reported.No fragment fell into the patient.The procedure was completed but the patient outcome was not provided.Isi followed up with the initial reporter and obtained the following additional information: "i am unsure of any of the answers to the other questions as the instrument was cleaned and returned to me with no other information.I noticed the wheel missing on the cartridge and that the wire wire/cable was dislodged".There was a loose cable (cable dislodged but still intact)."this was specified on the original rma, loose wire intact and wheel missing from cartridge".No material missing or detached from the instrument at the distal end.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis.The force bipolar instrument was analyzed and found to have the grip cable loose at the distal end that was showing out.A loose grip cable at the distal end is often caused by something else in the backend (ex: broken cable, cracked clamping pulley, loose clamping pulley screw).The plastic housing was removed, and the grip cable was broken at the clamping pulley.The clamping pulleys did not exhibit signs of corrosion/contamination that would have contributed to the cable breakage.The complaint regarding a loose cable was confirmed by failure analysis.Common causes of broken: proximal instrument grip cables are attributed to damage to the cable during use or during reprocessing.

• Brand Name: ENDOWRIST
• Common Device Name: FORCE BIPOLAR
• 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: 22946961
• Report Number: 2955842-2025-36530
• Device Sequence Number: 13075771
• Product Code: NAY
• UDI-Device Identifier: 00886874115930
• UDI-Public: (01)00886874115930(10)N/A
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K180351
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Other,Notification
• Type of Report: Initial
• Report Date (Section B): 08/05/2025

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: 470405-06
• Device Catalogue Number: 470405
• Device Lot Number: K10250409 0229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2022
• 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: ISIFA2024-09-C
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Unknown