MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; PK DISSECTING FORCEPS

Model Number	420227-10
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted radical cystectomy surgical procedure, the instrument was unable to be controlled and the cable was found to be broken.A backup instrument was used and the procedure was completed with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the dissecting forceps involved with this complaint and completed the device evaluation.Failure analysis investigations confirmed the customer reported complaint of "found the cable snap".Failure analysis found the primary failure of a broken conductor wire at the yaw pulley exit.The wire was detached from its connection at the grip.The yaw pulley showed no signs of arcing.Due to the broken conductor wire, the electrical continuity test could not be performed.The instrument was found to have a broken bipolar yaw pulley.A broken piece approximately.065 x.211 was missing because of the breakage.This failure is typically associated with mishandling/misuse, such as excess force applied to the distal end of the instrument.Root cause of this failure is attributed to user.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: PK DISSECTING FORCEPS
• 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: 16925259
• Report Number: 2955842-2023-13182
• Device Sequence Number: 6930508
• Product Code: NAY
• UDI-Device Identifier: 00886874111673
• UDI-Public: (01)00886874111673(10)N10190826
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K061260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/11/2021

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: 420227-10
• Device Catalogue Number: 420227
• Device Lot Number: N10190826 147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2021
• Initial Report FDA Received Date: 05/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2019
• 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