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

Model Number	430011-57
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted myomectomy surgical procedure, the jaw of the fenestrated bipolar forceps instrument was broken.The user continued and completed the procedure as planned.No fragment fell into the patient.No known impact or patient consequence was reported.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained additional information: the reporter stated that they dropped the instrument on the floor and picked it up and noticed that the jaw was completely broken off.No fragments fell into the patient, and there was no patient injury.Nothing was missing from the instrument.The user replaced the instrument with a spare one.The instrument did not collide with any other instruments or other hard material during the surgical procedure.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the fenestrated bipolar forceps instrument for evaluation, but evaluation has not been completed as of the date of this report.Therefore, the root cause of the customer reported failure mode has not been determined.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The fenestrated bipolar forceps instrument was analyzed and found to have a broken molded insulator on the lower jaw.The broken molded insulator likely caused the grip tip to be fully detached.The broken piece was returned with the instrument.The grip base for the grip with the cracked molded insulator does not appear to be bent.A visual inspection found no external damage to the housing or main tube.The housing was removed for inspection and found no internal damage.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.The instrument was found to have a detached fragment.Smaller fragments were not returned and were likely caused by the broken over molded insulator.The entire lower grip tip was detached and was returned.The bipolar instrument's conductor wire was found to be broken and was likely caused by the broken over molded insulator.The wire is on the side with the lower jaw.The wire appears to be sticking out and would fail electrical continuity.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.
Event or Problem Description
Refer to h11 for follow-up information.

• 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: 23722125
• Report Number: 2955842-2025-47516
• Device Sequence Number: 13286975
• Product Code: NAY
• UDI-Device Identifier: 00886874114339
• UDI-Public: (01)00886874114339(11)240229(10)K10240229
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K182371
• 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): 12/18/2025

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: 430011-57
• Device Catalogue Number: 430011
• Device Lot Number: K10240229 0005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/14/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/29/2024
• 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