MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; NEEDLE DRIVER

Model Number	420117-04
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the needle driver instrument involved with this complaint and completed the device evaluation.Failure analysis investigations confirmed the customer reported complaint.Failure analysis found the primary failure of insulation damage to be related to the customer reported complaint.The instrument was found to have insulation damage to the main tube.The main tube insulation was found to have a missing piece that was not returned with the instrument, measuring.085" x.114".The root cause of this failure is attributed to mishandling/misuse.Review of the provided image is consistent with the alleged complaint of "peeled insulation".The image shows insulation damage that is lifted or peeled on the main tube of the instrument below the wrist proximally.Root cause of the failure mode cannot be confirmed without the returned device.No further escalations required for the image review.
Event or Problem Description
It was reported that after a da vinci-assisted surgical procedure, the needle driver instrument presented a loss of integrity in its extension (peeled).The procedure was completed with the same instrument with no reported injury.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: NEEDLE DRIVER
• 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: 16883468
• Report Number: 2955842-2023-12787
• Device Sequence Number: 17599961
• Product Code: NAY
• UDI-Device Identifier: 00886874111369
• UDI-Public: (01)00886874111369(10)S10100111
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/02/2021

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: 420117-04
• Device Catalogue Number: 420117
• Device Lot Number: S10100111 533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 05/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2010
• 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