MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC FORCE FEEDBACK; FORCE FEEDBACK MARYLAND BIPOLAR FORCEPS

Model Number	475172-10
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The force feedback maryland bipolar forceps was analyzed and found to have a broken main tube approximately 80.15mm from the distal tip.A piece measuring approximately 7.78 mm x 16.29 mm was not returned with the instrument.The instrument was found to have a broken inner tube approximately 68.29 mm from the distal tip.Upon visual inspection, the main tube holder was found to be dislodged from its normal position.The main tube holder was found to be broken.The broken regions measured approximately 1.17 mm x 1.70 mm in size.The fragments were not returned along with the instrument.The instrument was found to have a bent inner tube.The bending damage is located at the proximal end of the inner tube.The complaint was confirmed by failure analysis, which indicates that the device may have contributed to the customer reported issue.
Event or Problem Description
It was reported that the force feedback maryland bipolar forceps had an unknown issue.It was found in the defective collection container with no note.The procedure was completed as planned with no reported injury.

• Brand Name: FORCE FEEDBACK
• Common Device Name: FORCE FEEDBACK 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: 22058285
• Report Number: 2955842-2025-21102
• Device Sequence Number: 8468770
• Product Code: NAY
• UDI-Device Identifier: 00886874120736
• UDI-Public: (01)00886874120736(10)U10240813
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K232610
• 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): 05/13/2025

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: 475172-10
• Device Catalogue Number: 475172
• Device Lot Number: U10240813 0059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2024
• 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: Reuse
• 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