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

Model Number	420172-18
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2024
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 pitch cable dislodged in the housing at the proximal end.The instrument housing was removed and found that the pitch cable was dislodged.The dislodged pitch cable caused loose pitch cable at the distal end.This results to the mouth not moving freely.The instrument was found to have charring and/or localized melting on the outer surface of one bipolar yaw pulley at the base of the grip.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 did indicate that a monopolar instrument was used during this case.The complaint was confirmed by failure analysis.Blank mdr fields: the missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Information for the blank fields in section e1 is not available.Fields g5 and g7 are not applicable.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the 8mm maryland bipolar forceps instrument's mouth movement was not free and could not reach the surgical site.The surgeon could not perform the operation normally.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: arcing was not observed during the procedure.No patient injury or harm.

• Brand Name: ENDOWRIST;DAVINCI SI
• 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: 20766185
• Report Number: 2955842-2024-22319
• Device Sequence Number: 20965604
• Product Code: NAY
• UDI-Device Identifier: 00886874111475
• UDI-Public: (01)00886874111475(10)K10230615
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K050369
• 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
• Report Date (Section B): 11/04/2024

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: Health Professional
• Device Model Number: 420172-18
• Device Catalogue Number: 420172
• Device Lot Number: K10230615 180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 11/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2023
• 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: 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