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

Model Number	431150-02
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923); Unintended Movement (3026)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The force bipolar instrument was analyzed and found to have a broken molded insulator.A visual inspection was performed, and the instrument was observed to have a broken upper molded insulator on the grip tips, with fragments of the molded insulator observed to be detached.The broken piece measures approximately 2.1mm x9.7mm and was not returned with the instrument.The grip base for the grip with the cracked molded insulator does not appear to be bent.There was no external damage to the shaft, housing, or chassis.The release buttons were functional.The instrument was found to have a detached fragment.The instrument was observed to have detached upper molded insulator from the grip tips.The broken upper molded insulator was still attached to the instrument due to the conductor wire, but fragments of the upper molded insulator was observed detached.The detached fragment measures approximately 2.1mm x 9.7mm and was not returned with the instrument.The instrument was found to have a dislodged crimp.A visual inspection revealed that the instrument had a dislodged crimp from the control wrist cable, located at the distal end.The dislodged crimp is the likely caused by imprecise instrument motion.Due to the dislodged crimp, the instrument is unable to straighten the wrist.The instrument was found to have imprecise motion.Imprecise motion is likely caused by the dislodged crimp from the wrist control cable and not from the grip tips.The instrument was tested on the in-house system and imprecise motion was observed.Due to the dislodged crimp from the wrist control cable, the instrument wrist was unable to fully straighten and articulated to right, which contributed to the imprecise motion.The instrument passed tip detection and recognition.The instrument was unable to test for energy delivery, due to the broken molded insulator.The complaint was confirmed by failure analysis.The probable root cause is attributed to damage during use, which may result from applying excess force on the instrument tip during handling, insertion, usage (overloading), or removal.This issue can be resolved by using an alternate instrument to complete the procedure.
Event or Problem Description
It was reported that during da vinci-assisted surgical procedure, the force bipolar instrument had issue with gripping force.It was unknown if any fragment fell into the patient.The procedure was completed with no reported injury.Isi followed up with the initial reporter and obtained the following additional information: during the procedure, the instrument couldn¿t grasp the tissue.It was predicted that the wrist of instrument may be damaged.No fragment fell into the patient.There was no reported injury.

• Brand Name: ENDOWRIST SP
• Common Device Name: FORCE BIPOLAR ER
• 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: 25051068
• Report Number: 2955842-2026-23502
• Device Sequence Number: 18744588
• Product Code: NAY
• UDI-Device Identifier: 00886874124055
• UDI-Public: (01)00886874124055(11)250501(10)K11250501
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K241814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/30/2026

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: 431150-02
• Device Catalogue Number: 431150
• Device Lot Number: K11250501 0012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2025
• 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