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

Model Number	430010-62
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/02/2026
Type of Reportable Event	Malfunction

• 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 ; +1(408)523-2100
• MDR Report Key: 50217205
• Report Number: 2955842-2026-34955
• Device Sequence Number: 6098753
• Product Code: NAY
• UDI-Device Identifier: 00886874114322
• UDI-Public: (01)00886874114322(11)241121(10)K11241121
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K182371
• 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
• Report Date (Section B): 08/11/2026

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: 430010-62
• Device Catalogue Number: 430010
• Device Lot Number: K11241121 0023
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/09/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/25/2026
• Initial Report FDA Received Date: 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2024
• 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
• Patient Sex: Unknown