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

Model Number	431150-02
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the sp force bipolar instrument tip broke while in use.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the customer clarified that the broken instrument tip resulted in a fragment falling off when the instrument was removed from the patient.The fragment fell off outside of the patient, there was no patient injury related to the issue.
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 instrument 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.
Additional Manufacturer Narrative
Intuitive surgical inc.(isi) received the sp force bipolar instrument for failure analysis investigation.The instrument was analyzed and found to have a broken molded insulator on the upper jaw.The broken pieces measure approximately 1.57mm x 7.92mm and were returned with the instrument.The grip base for the grip with the cracked molded insulator does not appear to be bent.The instrument was found to have a detached fragment.The detached fragment(s) broken off from the instruments molded insulator.The broken pieces were returned.The common causes of the failure mode broken molded insulator can result from mechanical impact or excessive force applied to the jaws, such as an accidental drop of the instrument.The instrument was found to have a detached intact grip.The upper grip of the instrument became detached due to the break in the molded insulator.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical inc.(isi) received the sp force bipolar instrument for failure analysis investigation.The instrument was analyzed, and the initial findings were confirmed.Because the bipolar conductor wire associated with grip with the broken molded insulator is intact, the remains of the grip were still attached to the instrument by the wire.Inspection of the grip which does not have a broken molded insulator did not find any additional observations.Inspection of the grip with the broken molded insulator found the grip base to exhibit torsional, or twisting, bending which can be caused by excessive force in a twisting direction.The probable root cause of broken molded insulator and detached fragment is attributed to damage during use, which may result from applying excess force on the instrument tip during handling, insertion, usage (overloading), or removal.Inspection of the grip with the broken molded insulator revealed torsional, or twisting, deformation of the grip base, likely caused by the application of excessive force in a twisting motion.This issue can be resolved by using an alternate instrument to complete the procedure.Correction: h8.Was updated to initial use of device.

• 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: 22919074
• Report Number: 2955842-2025-36029
• Device Sequence Number: 9676604
• Product Code: NAY
• UDI-Device Identifier: 00886874124055
• UDI-Public: (01)00886874124055(11)250515(10)K10250515
• 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,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2025

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: 431150-02
• Device Catalogue Number: 431150
• Device Lot Number: K10250515 0002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/12/2025
• Supplement Date Received by Manufacturer: 09/03/2025; 10/14/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 09/29/2025; 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2025
• 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