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

Model Number	430011-57
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, single port (sp) fenestrated bipolar forceps instrument had misaligned jaws.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis.The single port (sp) fenestrated bipolar forceps instrument was analyzed and found to have one severely bent grip, causing misalignment of the grip tips.There was a 1.60 mm offset at the tips.The grips were found to have cracking damage.A molded insulator was found to be broken.The instrument was found to have a broken molded insulator on the upper jaw.The broken piece measures approximately 1.37 mm x 1.85 mm, confirming that a fragment detached from the instrument and was not returned with the instrument.The grip base for the grip with the cracked molded insulator does appear to be bent.The complaint regarding misaligned jaws was confirmed by failure analysis.The probable root cause can be attributed to mechanical impact or excessive force applied to the jaws, such as an accidental drop of the instrument.

• 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 ; +1(408)523-2100
• MDR Report Key: 50864100
• Report Number: 2955842-2026-39714
• Device Sequence Number: 18809880
• Product Code: NAY
• UDI-Device Identifier: 00886874114339
• UDI-Public: (01)00886874114339(10)U10220901
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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: 430011-57
• Device Catalogue Number: 430011
• Device Lot Number: U10220901 0014
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/17/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• 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