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

Model Number	420143-04
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	09/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the maryland dissector involved with this complaint and completed the device evaluation.The reported complaint was confirmed during failure analysis (fa).The instrument was found to have a broken snake wrist cable at the distal end.Additionally, the instrument's nylon insulation main tube was found to have insulated damage.A piece measuring approximately 0.062" x 0.089" was found missing.The root cause of this failure is due to mishandling/misuse.
Event or Problem Description
It was reported that during a da vinci-assisted tongue base resection surgical procedure, the single-site maryland dissector instrument peeled off the clamp body and had broken steel wires.The procedure was completed with the same instrument with no reported injury.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: MARYLAND DISSECTOR
• 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: 16883419
• Report Number: 2955842-2023-12749
• Device Sequence Number: 20676495
• Product Code: NAY
• UDI-Device Identifier: 00886874111413
• UDI-Public: (01)00886874111413(10)S10120504
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 12/05/2020

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: 420143-04
• Device Catalogue Number: 420143
• Device Lot Number: S10120504 200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2020
• Initial Report FDA Received Date: 05/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2012
• 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