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

Model Number	430151-02
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the single port fenestrated bipolar forceps instrument to perform failure analysis.The instrument was found to have one severely bent grip causing misalignment of the grip-tips.There was a 1.92mm offset at the tips.The grips were not found to have cracking damage.The probable root cause of severely bent grips is attributed to damage either during use or reprocessing, as severe misalignment of grip tips can be due to accidental drops, incorrect instrument tray or sink sizes for reprocessing, or overloading the tips.Additional findings related to the reported complaint: the instrument was found to have a dislodged molded insulator on the jaw.The grip tip for the grip with the dislodged molded insulator does appear to be bent.Components adjacent to the dislodged molded insulator do not show damage.The probable root cause is attributed to mechanical impact or excessive force applied to the jaws, such as an accidental drop of the instrument.The missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Field e4 is blank because it is unknown if the initial reporter submitted a report to the fda.Fields g5 and g7 are not applicable.Field h10 is blank as there are no related report numbers.
Event or Problem Description
It was reported that prior to the start of a da vinci-assisted surgical procedure, a single port fenestrated bipolar forceps instrument was found to have misaligned tips.The customer reported event had no report of patient injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument was not connected to the system during this surgery.No arcing was reported in prior surgeries.

• 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: 25011166
• Report Number: 2955842-2026-23056
• Device Sequence Number: 16035575
• Product Code: NAY
• UDI-Device Identifier: 00886874123447
• UDI-Public: (01)00886874123447(10)K10260115
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 04/27/2026

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: 430151-02
• Device Catalogue Number: 430151
• Device Lot Number: K10260115 0025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2026
• 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