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

Model Number	430152-01
Medical Device Problem Codes	Break (1069); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2025
Type of Reportable Event	Malfunction
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 on the lower jaw.The broken molded insulator likely caused the grip tip to be semi-detached and also caused the jaws to not fully close.The grip base for the grip with the cracked molded insulator does not appear to be bent.Fragments that covered the cable connector were broken off and not returned.Visual inspection was performed and found no damage to the housing or main tube.The housing was removed for inspection and found no internal damages.The input disks were manually articulated with no issues.The grip knob was able to rotate, allowing the grips to open/close without any issues.Additional finding(s) related to the customer reported complaint: the instrument was found to have a detached fragment.The fragments were not returned and was likely caused by the broken over molded insulator.The lower grip tip was semi-detached with pieces broken off.The root cause is typically attributed to the user.The complaint was confirmed based on failure analysis.The probable root cause is attributed to the user.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the 6mm maryland bipolar forceps jaws would not close.The procedure was completed with no reported injury.

• 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: 23364714
• Report Number: 2955842-2025-42606
• Device Sequence Number: 12981691
• Product Code: NAY
• UDI-Device Identifier: 00886874123461
• UDI-Public: (01)00886874123461(10)H10250417
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/02/2025

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: 430152-01
• Device Catalogue Number: 430152
• Device Lot Number: H10250417 0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2025
• 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 Sex: Unknown