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

Model Number	430011-57
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during central processing, the tips of the single port (sp) fenestrated bipolar forceps instrument will not align.There was no report of patient involvement.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The single port (sp) fenestrated bipolar forceps instrument was analyzed.The instrument was found to have bent grip, causing them to be misaligned.The offset at the tips was 0.48mm.The grips were not found to be cracked.Upon further inspection, the instrument was found to have thermal damage on the molded insulator portion of the upper grip tip.Additionally, the instrument had the conductor wire dislodged from the connector pin, on the energy instrument identification board, inside the housing on the proximal end.The instrument failed the electrical continuity test.The conductor wire was reinserted on the connector pin, and it passed the electrical continuity test.The complaint was confirmed by failure analysis.The probable root cause of bent grips is attributed to damage during use, as moderate misalignment of grip tips can be due to grasping either hard tissue/objects or collisions with other instruments.

• 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: 25644635
• Report Number: 2955842-2026-30085
• Device Sequence Number: 17611644
• Product Code: NAY
• UDI-Device Identifier: 00886874114339
• UDI-Public: (01)00886874114339(10)U10220214
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Report Date (Section B): 06/26/2026

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: 430011-57
• Device Catalogue Number: 430011
• Device Lot Number: U10220214 0016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/11/2026
• Initial Report FDA Received Date: 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2022
• 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