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

Model Number	471171-15
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The instrument involved in this complaint has not been received and/or tested by failure analysis as of the date of this report.If the product is received and evaluated, a supplemental mdr will be submitted.
Event or Problem Description
It was reported that the customer experienced an issue with an intuitive product.The customer reported event has no report of patient injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the 8mm micro bipolar forceps instrument to perform failure analysis.The instrument was analyzed and it was found to have a damaged grip cable.Additional findings : the instrument was found to have damage of the conductor wire insulation at the yaw pulley.There were no material missing and the conductor wires were exposed.The instrument passed an electrical continuity test.The probable root cause of cable breakage, whether partial or full, is attributed to damage to the cable through external collisions, during use, or during reprocessing.The probable root cause of damaged conductor wire insulation is attributed to damage from mechanical impact.Accidental drops of the instrument or inadvertent collisions with other instruments or hard surfaces during handling or usage can damage the insulation.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: ENDOWRIST
• Common Device Name: MICRO 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: 23796288
• Report Number: 2955842-2025-48492
• Device Sequence Number: 10470745
• Product Code: NAY
• UDI-Device Identifier: 00886874121474
• UDI-Public: (01)00886874121474(11)231123(10)K10231123
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K214095
• 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,Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2026

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: 471171-15
• Device Catalogue Number: 471171
• Device Lot Number: K10231123 0018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/26/2025
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2023
• 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: ISIFA2024-09-C
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Unknown