MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; MONOPOLAR CAUTERY

Model Number	420142-08
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, a monopolar cautery instrument was bent out of shape and stuck on the cannula.A backup instrument was used.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.Failure analysis investigations confirmed the customer reported complaint.The instrument main tube was found bent.The bending damage is located at the distal end of the main tube.This failure is most commonly caused by misuse/mishandling, such as excessive loading, or improper handling during transport.A piece of the damaged insulation was found missing, measuring approximately 0.053" x 0.079" which is commonly caused by mishandling/misuse.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: MONOPOLAR CAUTERY
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 17015565
• Report Number: 2955842-2023-14703
• Device Sequence Number: 7500834
• Product Code: NAY
• UDI-Device Identifier: 00886874111406
• UDI-Public: (01)00886874111406(10)S10140924
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/27/2020

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: 420142-08
• Device Catalogue Number: 420142
• Device Lot Number: S10140924 370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 05/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2014
• 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