MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; PRECISE BIPOLAR FORCEPS

Model Number	420110-12
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the precise bipolar forceps instrument involved with this complaint and completed the device evaluation.Failure analysis investigations confirmed the customer reported complaint.The instrument was found to have a broken grip cable at the distal idler pulley.The distal idler pulley spun freely and did not exhibit any damage.The root cause is attributed to a component failure.Additional observation not reported was the instrument was found to have various scratch marks with light material removed on the main tube.The scratch marks were 0.087¿ - 0.157 in length and were not aligned with the tube axis.The root cause is typically attributed to mishandling / misuse.A review of the instrument log for the precise bipolar forceps instrument (pn# 420110-12 / lot# n10201207-451) associated with this event has been performed.Per logs, the instrument was last used on (b)(6) 2021 on system (b)(4) for approximately 1 minute 39 seconds.The alleged event occurred on the 10th use of the instrument with no lives remaining.A review of the site's complaint history does not reveal any related or duplicate complaints involving this product and/or this event.This complaint is being reported due to the following conclusion: failure analysis acknowledges material was missing from a portion of the device that enters the patient.Based on the information provided, there was no report from the customer that a fragment from the instrument fell into the patient during the procedure.While there was no report of harm or injury to the patient and no report of fragments falling into the patient, the reported failure mode could likely cause or contribute to an adverse event if the fragment(s) did fall into the patient.
Event or Problem Description
It was reported that during a da vinci-assisted prostatectomy surgical procedure, the precise bipolar forceps was found to have a torn cable.A backup instrument of the same kind was used to complete the procedure.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) has performed follow-up to request additional information related to the reported event.However, as of the date of this report, no further details have been received.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: PRECISE BIPOLAR 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: 13706756
• Report Number: 2955842-2022-10547
• Device Sequence Number: 17475855
• Product Code: NAY
• UDI-Device Identifier: 00886874111352
• UDI-Public: (01)00886874111352(10)N10201207
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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): 02/09/2022

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: 420110-12
• Device Catalogue Number: 420110
• Device Lot Number: N10201207 451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2020
• 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: Male