MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; LARGE HEM-O-LOK CLIP APPLIER

Model Number	420230-06
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the instrument associated with this complaint and completed investigations.Failure analysis investigations replicated/confirmed the customer reported complaint of loose cable.Visual inspection of the grip cables showed one of the cables was loose; however, they were not damaged.There was little to no tension when opening and closing the grips.The housing was removed and no damage was found to the cables.The root cause of the loose grip cable was attributed to component failure.In addition, the instrument was found to have corrosion on one or more clamping pulleys in the back end.The instrument was found to have the entire length of the main tube surface with degradation.The instrument was placed on the in-house system and failed the clip test.The instrument was placed on the in-house system and passed engagement and recognition.The clip test was performed and the clip failed to stay in the jaws.The grip functionality was not working to spec due to the loose grip cables.As a result the open and close function was not precise.
Event or Problem Description
It was reported that prior to starting a da vinci-assisted cholecystectomy surgical procedure, the large hem-o-lok clip applier instrument had a loose cable/cable off track.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument inspected prior to use.The color of the broken/loose cable was black and no damaged was found to the conductor wire insulation.The instrument did not collide with any other tool.There was no patient involvement.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: LARGE HEM-O-LOK CLIP APPLIER
• 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: 16926722
• Report Number: 2955842-2023-13248
• Device Sequence Number: 6920884
• Product Code: NAY
• UDI-Device Identifier: 00886874111680
• UDI-Public: (01)00886874111680(10)N10140319
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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): 03/12/2021

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: 420230-06
• Device Catalogue Number: 420230
• Device Lot Number: N10140319 060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 05/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2014
• 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 Age: 27 YR
• Patient Sex: Female
• Patient Weight: 150 KG