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

Model Number	410322-05
Medical Device Problem Codes	Image Display Error/Artifact (1304); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the vessel sealer (vs) instrument involved with this complaint and completed the device evaluation.Failure analysis investigation confirmed the customer reported complaint.Failure analysis found the primary failure of low grip torque to be related to the customer reported complaint.The instrument was found to have multiple low grip torque failures based on log review and was replicated during in-house testing.The instrument was placed and driven on an in-house system.The instrument passed the recognition and engagement tests.A recoverable fault would occur during every attempt to cut and deliver energy.Upon visual inspection, there was no blade exposed outside of the blade garage and the knife slot measured at 0.029.The jaw gap verification and grip force test could not be performed due to low grip torque failures.Electrical continuity was tested and passed.Root cause of low grip torque failures is not determinable/applicable.Failure analysis found the secondary failure of stripped clamping nut to be related to the customer reported complaint.Upon inspection, the instrument was found to have a stripped clamping nut at the distal wrist, likely causing the low grip torque failures.The grip tips intermittently failed to open and close completely.Root cause of stripped clamping nut is attributed to a device design.Instrument overmold nut/clamping nut was confirmed as stripped.The jaws intermittently failed to open and close, and during investigation the threads stripped out completely, leaving the grips unable to be opened via the input disc or the grip open lever.On the system, the stripped overmold nut led to the 23107 error (low grip torque).A review of the instrument log for the vessel sealer instrument (pn: 410322-05/lot #m10191009-759) associated with this event has been performed.Per logs, the instrument was installed on system sh0659 on reported procedure date of (b)(6) 2020.The instrument is single-use.There was no photo or video provided by the site for review.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.This complaint is being reported because the endowrist vessel sealer was found to have stripped threading on the overmold nut with no allegation of user mishandling or misuse.This failure could lead to clamping/unclamping issues.While there was no harm or injury to patient, the reported failure mode could cause or contribute to an adverse event if it were to recur.Follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable.The expiration date for device is not applicable.Implant date is not applicable because the product is not implantable.Information for the initial reporter is not available.Recall is not applicable.
Event or Problem Description
It was reported that prior to starting a da vinci-assisted surgical procedure, the system reflected an error message pointing to the vessel sealer (vs) instrument.The procedure was completed with no reported injury.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: VESSEL SEALER
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 11016766
• Report Number: 2955842-2020-11353
• Device Sequence Number: 3594582
• Product Code: NAY
• UDI-Device Identifier: 10886874111113
• UDI-Public: (01)10886874111113(10)M10191009
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K110639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/20/2020

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: M10191009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2020
• Initial Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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