MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST SP; FENESTRATED BIPOLAR FORCEPS

Model Number	430151-02
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the sp fenestrated bipolar forceps instrument did not move as commanded by the surgeon.The procedure was completed with no reports of patient injury.Intuitive followed up with the customer and was advised that it is unknown if the instrument moved in the same direction of the surgeon's commands, or in the opposite direction.
Additional Manufacturer Narrative
Intuitive surgical inc.(isi) received the single port (sp) fenestrated bipolar forceps instrument for failure analysis investigation.The instrument was analyzed and a dislodged cable crimp makes the cable appear to be broken.The crimp is located approximately 32.34 mm from the distal tip.The crimp was found approximately 39mm from the distal tip.Due to the dislodged crimp, the instrument failed manual articulation at the yaw input and exhibited imprecise motion when tested on the in-house system.Additionally, the sp fenestrated bipolar forceps instrument was installed on an in-house system and driven.The instrument exhibited imprecise motion in the yaw direction.The grip tips moved in the direction commanded; a lag or delay in the motion was observed due to the dislodged crimp.The instrument passed engagement and recognition.The probable root cause is attributed to the instrument experiencing more load than anticipated.The cable crimp can become dislodged due to back-driving of wrist and joggle joints with the insertion axis.Applying excessive force on the instrument shaft and/or tip during handling, insertion, usage (overloading), or removal can also cause the crimp to dislodge.

• Brand Name: ENDOWRIST SP
• Common Device Name: FENESTRATED BIPOLAR FORCEPS
• 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: 25339147
• Report Number: 2955842-2026-25874
• Device Sequence Number: 10128665
• Product Code: NAY
• UDI-Device Identifier: 00886874123447
• UDI-Public: (01)00886874123447(11)260226(10)K10260226
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K241814
• 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
• Report Date (Section B): 05/29/2026

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: 430151-02
• Device Catalogue Number: 430151
• Device Lot Number: K10260226 0018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 05/29/2026
• 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.
• Patient Sex: Unknown