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

Model Number	475205-10
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has requested that the fenestrated bipolar forceps instrument be returned for failure analysis testing.Isi did receive a da vinci product involved with this complaint to perform failure analysis (fa) testing.The product has been received and the fa is still in progress.
Event or Problem Description
It was reported that during central processing, the force feedback fenestrated bipolar forceps had melted plastic component of the jaws.The procedure was completed as planned with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: damage was identified at the beginning of the decontamination process.The damage was observed after use in the operating room.Before then, no damage was noted.The damage was not identified during procedure.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The instrument was analyzed and was found to have charring and/or localized melting on the outer surface of one bipolar yaw pulley.As a result of the damage, a section of the active electrode (grip) is exposed that would not normally be exposed.The instrument passed the electrical continuity test.A review of the procedure logs indicated that a monopolar instrument was used during this case.This instrument will be transferred to engineering for further investigation.The complaint was confirmed by failure analysis.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The instrument was analyzed and the initial findings were confirmed.One of the bipolar yaw pulleys exhibited charring and localized melting to its outer surface near the base of the grip, indicating thermal damage.No other damage was observed to the instrument.The tool table from the procedure confirmed that monopolar instruments were in use during the same time as this instrument.The root cause of this failure is attributed to the user to inadvertent energy application from a monopolar instrument while in close proximity to the bipolar instrument.The complaint was confirmed by failure analysis, which indicates that the device may have contributed to the customer reported issue.The probable root cause is attributed to the user.
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: 20331509
• Report Number: 2955842-2024-19635
• Device Sequence Number: 21233185
• Product Code: NAY
• UDI-Device Identifier: 00886874120743
• UDI-Public: (01)00886874120743(10)U10240625
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/04/2024

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: Other
• Device Model Number: 475205-10
• Device Catalogue Number: 475205
• Device Lot Number: U10240625 0080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/04/2024
• Supplement Date Received by Manufacturer: 10/15/2024; 02/07/2025
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 11/07/2024; 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2024
• 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: Prefer Not To Disclose