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

Model Number	430152-02
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The maryland bipolar forceps instrument has not been received for failure analysis evaluation.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the tip fell off the maryland bipolar forceps instrument during dissection.The procedure was completed.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument was inspected prior to use and showed no initial damage.During a dissecting task, a fragment fell inside the patient due to a collision with another instrument.The cause of the breakage was unknown, but the fragment was retrieved during the same procedure, and all fragments were visually confirmed as retrieved.During final removal, the wrist was straightened and there was no resistance felt; there was damage to the instrument and cannula.There was no patient injury, and no additional surgical procedures or post-operative tests were required.The procedure was completed robotically, and the instrument is available for return to intuitive surgical, inc.(isi) for evaluation.
Additional Manufacturer Narrative
Device evaluation: intuitive surgical, inc.(isi) received the maryland bipolar forceps (single port) instrument to perform failure analysis.The 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 lower molded insulator.The broken piece measured approximately 4.1mm x 15mm in size and was returned with the instrument.However, a detached fragment from the lower molded insulator was missing, measuring approximately 1.8mm x 8mm in size.The broken lower molded insulator likely caused the detached fragment.The grip base for the grip with the cracked molded insulator did not appear to be bent.There was no external damage to the shaft, housing, and snake wrist cables.Each input disk was manually articulated and responded accordingly, and the release buttons were functional.Additionally, the instrument was found to have a broken conductor wire located near the distal tip.The broken conductor wire was caused by the broken lower molded insulator.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: ENDOWRIST SP
• Common Device Name: MARYLAND 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: 24544217
• Report Number: 2955842-2026-15397
• Device Sequence Number: 5573180
• Product Code: NAY
• UDI-Device Identifier: 00886874123461
• UDI-Public: (01)00886874123461(11)250910(10)K10250910
• 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,Followup
• Report Date (Section B): 04/08/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 430152-02
• Device Catalogue Number: 430152
• Device Lot Number: K10250910 0014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2026
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2025
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown