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

Model Number	475205-10
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An rma was issued to evaluate the intuitive surgical, inc.(isi) device.Additional information is being gathered to determine the contribution of the device to the customer reported issue.A follow-up mdr will be submitted if the instrument is returned (post failure analysis evaluation) or if additional information is received.
Event or Problem Description
It was reported that during central processing, the shaft was broken off from the force feedback fenestrated bipolar forceps.There was no reported patient impact or harm.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The force feedback fenestrated bipolar forceps was analyzed and found to have a roll tube receiver broken at the proximal end.The broken piece was still attached to the instrument.Components adjacent to this broken roll tube receiver show damage which may indicate potential mishandling/misuse.A dislodged main tube holder was observed.Further investigation confirmed additional observations.Upon visual inspection, the main tube holder was found to be dislodged from its normal position.The complaint was confirmed by failure analysis, which indicates that the device may have contributed to the customer reported issue.
Additional Manufacturer Narrative
The force feedback fenestrated bipolar forceps was analyzed and the roll tube receiver was confirmed to be broken which caused the main tube/shaft to appear bent.It was additionally observed that the instrument was found to have a broken chassis; the t-tabs located on the bottom part of the chassis were broken.The broken pieces were still installed inside the main tube holder, no material was missing.As a result, the main tube assembly was found to be dislodged from its normal position.There was no damage observed to the main tube holder or the main tube.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: FORCE FEEDBACK
• Common Device Name: FORCE FEEDBACK 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: 21024340
• Report Number: 2955842-2024-23680
• Device Sequence Number: 8191712
• Product Code: NAY
• UDI-Device Identifier: 00886874120743
• UDI-Public: (01)00886874120743(10)U10240802
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup,Followup
• Report Date (Section B): 12/13/2024

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: 475205-10
• Device Catalogue Number: 475205
• Device Lot Number: U10240802 0055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/13/2024
• Supplement Date Received by Manufacturer: 04/17/2025; 06/05/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 04/29/2025; 06/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2024
• 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