MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; VESSEL SEALER

Model Number	410322-05
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	10/19/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted hysterectomy surgical procedure, the blade of the vessel sealer instrument was exposed.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the vessel sealer involved with this complaint and completed the device evaluation.The reported complaint was confirmed during failure analysis.The instrument was found to have dislodged blade.Visual inspection showed that the blade was exposed outside of the blade garage 0.132".There was significant bio debris found at the instrument tip and the knife slot measured at 0.029".A review of remotefe log showed 1 number of blade exposed failure(s).After manually retracting the blade, the instrument was placed on the in-house system and continued to fail self-check.The root cause of dislodged blade is attributed to mishandling.Additional findings not reported by site: the instrument was found to have a dislodged snake wrist.This failure is most commonly caused by mishandling/misuse, such as an accidental drop or other sudden impact.Root cause of dislodged snake wrist is attributed to mishandling.The instrument was found to have a conductor wire with insulation damage at the distal end.Electrical continuity was performed and passed.Root cause of conductor wire insulation damage is attributed to mishandling.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: VESSEL SEALER
• 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: 17046669
• Report Number: 2955842-2023-15513
• Device Sequence Number: 17404500
• Product Code: NAY
• UDI-Device Identifier: 10886874111113
• UDI-Public: (01)10886874111113(10)M10190918
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K110639
• 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): 11/17/2020

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: 410322-05
• Device Catalogue Number: 410322
• Device Lot Number: M10190918 551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian