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

Model Number	431150-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The single port (sp) force bipolar extended range instrument has been returned and evaluated by the failure analysis (fa) team.Failure analysis found the primary finding of instrument molded insulators - broken to be related to the customer reported complaint.The instrument was found to have a broken molded insulator on the upper jaw.The broken molded insulator likely caused the grip tip to be fully detached.The broken piece was not returned with the instrument.The grip base for the grip with the cracked molded insulator does not appear to be bent.Visual inspection was performed and found no damage to the housing or main tube.The housing was removed for inspection and found no internal damages.The input disks were manually articulated with no issues.The grip knob was able to rotate, allowing the grips to open/close without any issues.Additionally, the instrument was found to have a detached fragment.The fragment was not returned and was likely caused by the broken over molded insulator.The entire upper grip tip was detached.The bipolar instrument's conductor wire was found to be broken.The broken wire was likely caused by the broken over molded insulator.The location of the wire is on the side with the upper jaw.The wire appears sticking out and would fail electrical continuity.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.
Event or Problem Description
It was reported that during central processing, the single port (sp) force bipolar extend tip broke/slid off during cleaning.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
The probable root cause of the broken molded insulator and detached fragment is attributed to damage sustained during use, likely due to excessive force applied to the instrument tip during handling, insertion, operation (overloading), or removal.The damaged molded insulator subsequently led to the breakage of the instrument¿s conductor wire.
Event or Problem Description
Refer to h11 for follow-up information.

• 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: 23387911
• Report Number: 2955842-2025-42986
• Device Sequence Number: 11994317
• Product Code: NAY
• UDI-Device Identifier: 00886874124055
• UDI-Public: (01)00886874124055(10)H10250616
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 10/30/2025

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: 431150-01
• Device Catalogue Number: 431150
• Device Lot Number: H10250616 0022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/01/2025
• Supplement Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 10/26/2025
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2025
• 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