MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC EndoWrist; PERMANENT CAUTERY HOOK

Model Number	470183-19
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted cholecystectomy procedure, the permanent cautery hook (pch) instrument broke into pieces.One piece was retrieved and two plastic pieces were noted to be missing.The customer confirmed that intraoperative imaging was performed to look for the remaining two fragments.Hence, the procedure was completed with a delay of approximately 2 hours.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the permanent cautery hook (pch) instrument to perform failure analysis.The instrument was analyzed and found to have a broken monopolar yaw pulley at the distal clevis.Broken pieces are missing as a result of breakage.The size of the missing piece is approximately 5.96mm x 6.05mm.The components surrounding the break did not exhibit damage that would have contributed to the broken yaw pulley.

• Brand Name: EndoWrist
• Common Device Name: PERMANENT CAUTERY HOOK
• 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 ; +1(408)523-2100
• MDR Report Key: 50873400
• Report Number: 2955842-2026-39315
• Device Sequence Number: 18809946
• Product Code: NAY
• UDI-Device Identifier: 00886874112311
• UDI-Public: (01)00886874112311(10)K12260226
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K131861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Model Number: 470183-19
• Device Catalogue Number: 470183
• Device Lot Number: K12260226 0002
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/16/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Weight: 350 LB