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

Model Number	430152-02
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted radical prostatectomy with lymphadenectomy surgical procedure, the maryland bipolar forceps instrument's tip broke.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The maryland bipolar forceps 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 detached from the instrument.For clarification, the upper molded insulator and grip tip was still attached to the instrument due to the conductor wire.There were no missing pieces or detached fragments of the molded insulator observed.The instrument was tested with the multimeter and passed continuity test.There was no external damage to the shaft, housing, or snake wrist cables.Each input disk was manually articulated and responded accordingly.The release buttons were functional.The instrument was found to have corroded bearings.The housing was removed for inspection and orange discoloration was observed on three bearings near the input capstan, which indicates corrosion.The complaint was confirmed by failure analysis.The sheath also was returned, and a visual inspection was performed and there was no external damage found.The sheath coextrusion inside the sheath is intact and no damage was observed.There were no punctures or tears on the sheath.The sheath was installed on an in-house instrument, and the molded clip was clicked in place without any issues or friction.The sheath was then removed from the in-house instrument and no issues were seen.The sheath is fully functional and no issues were found.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.The probable root cause is attributed to improper cleaning or sterilization techniques used in reprocessing, which may include prolonged exposure of the instrument to harsh cleaning agents or insufficient flushing.

• 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: 24707016
• Report Number: 2955842-2026-18872
• Device Sequence Number: 16068036
• Product Code: NAY
• UDI-Device Identifier: 00886874123461
• UDI-Public: (01)00886874123461(10)K10250926
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/26/2026

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: 430152-02
• Device Catalogue Number: 430152
• Device Lot Number: K10250926 0008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2025
• 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 Age: 66 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White