MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; PK DISSECTING FORCEPS

Model Number	420227-10
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive has received the part associated with this complaint and completed investigations.Failure analysis investigations replicated/confirmed the customer reported complaint.Failure analysis found the primary finding of conductor wire broken to be related to the customer reported complaint.The instrument was found to have a broken conductor wire at the yaw pulley exit.The wire was detached from its connection at the grip.The yaw pulley showed no signs of arcing.Due to the broken conductor wire the electrical continuity test is not required.Root cause of this failure is attributed to a component failure.Additional finding not reported by the site: the instrument was found to have a broken bipolar yaw pulley.Broken piece is missing as a result of breakage.Size of missing piece is approximately 0.046 x 0.135 which was not returned for failure analysis.The instrument was found to have various scratch marks with light material removed on the main tube.The scratch marks were 0.039 - 0.124 in length and were not aligned with the tube axis.Root cause of these failures is likely attributed to mishandling/misuse.Blank mdr fields: the missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Information for the blank fields in section e1 is not available.Field e4 is blank because it is unknown if the initial reporter submitted a report to the fda.Fields g5 and g7 are not applicable.
Event or Problem Description
It was reported that during central processing, the pk dissecting forceps was observed to having an exposed wire.There was no report of patient involvement.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: PK DISSECTING FORCEPS
• 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: 17015557
• Report Number: 2955842-2023-14675
• Device Sequence Number: 7500828
• Product Code: NAY
• UDI-Device Identifier: 00886874111673
• UDI-Public: (01)00886874111673(10)N10200317
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K061260
• 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): 03/04/2021

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: 420227-10
• Device Catalogue Number: 420227
• Device Lot Number: N10200317 377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 05/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2020
• 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