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

Model Number	420110-12
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2022
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 (fa) investigation confirmed the customer reported complaint.Fa found the primary failure of broken conductor wire to be related to the customer complaint.For clarification, the instrument was found to have a broken conductor wire at the yaw pulley on the distal end.The conductor wire was completely broken at the grip-crimp location.The instrument failed the electrical continuity test.No insulation damage was found.No signs of thermal damage were observed.No cables exhibited any signs of fraying or breakage.The housing was removed from the back end, no damage was observed.The root cause for the broken conductor wire is attributed to a component failure.Additionally, the instrument was found to have a broken bipolar yaw pulley.The broken piece is missing as a result of breakage.Size of missing piece is approximately 0.054¿ x 0.223¿.The root cause of broken instrument bipolar yaw pulley was typically attributed to the user, such as excess force applied to the distal end of the instrument.A review of the device logs for the precise bipolar forceps (part# 420110-12 | lot/serial# (b)(4)) associated with this event has been performed.Per this review of the logs, the precise bipolar forceps was last used on (b)(6) 2022 via system serial# (b)(4).There were 1 uses remaining after this last usage.No image or procedure video was provided for review.This complaint is being classified as a reportable event due to the following conclusion: failure analysis acknowledges that a fragment was missing from a portion of the device that enters the patient (distal end).While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.
Event or Problem Description
It was reported that during central processing, the precise bipolar forceps instrument was noted to have broken cable.There was no report of patient involvement.Intuitive surgical, inc.(isi) followed up with the initial reporter and patient demographic information was requested, but not provided.

• 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: 15501768
• Report Number: 2955842-2022-14251
• Device Sequence Number: 15411909
• Product Code: NAY
• UDI-Device Identifier: 00886874111352
• UDI-Public: (01)00886874111352(10)N10190923
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 08/29/2022

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: N10190923 437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2022
• Initial Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2019
• 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