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

Model Number	420142-09
Medical Device Problem Codes	Unintended Movement (3026); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after central processing, while preparing instruments for the case planned, it is found that monopolar cautery instrument was having rigid movement and snake wrist was not moving freely to all direction while physically moving the same.The instrument was not installed and alternate instrument was used for the procedure.Intuitive surgical, inc.(isi) followed up and obtained the following additional information: the clinical sales representative (csr) informed that the issue was noticed before the start of the procedure.The ports were not placed on the patient.The instrument was not used as it was having rigid movements.
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The monopolar cautery instrument was analyzed and the reported failure was confirmed.The instrument was found to have exhibited unintuitive motion (moved precisely and proportionally to the master, started and stopped with master motion, just moved in the wrong direction) when placed and driven on an in-house system.Further evaluation found the instrument had a broken snake wrist cable at the distal end.The complaint was confirmed by failure analysis, which indicates that the device may have contributed to the customer reported issue.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.Field e4 is blank because it is unknown if the initial reporter submitted a report to the fda.Fields g5 and g7 are not applicable.

• 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: 17980960
• Report Number: 2955842-2023-19459
• Device Sequence Number: 3470526
• Product Code: NAY
• UDI-Device Identifier: 00886874111406
• UDI-Public: (01)00886874111406(10)T10190325
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 09/28/2023

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: 420142-09
• Device Catalogue Number: 420142
• Device Lot Number: T10190325 512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2019
• 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