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

Model Number	420207-10
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted myomectomy surgical procedure, the tenaculum forceps instrument was found to have a broken wire.A backup instrument of same kind was used to continue the procedure.There was no report of fragment(s) falling inside the patient.The procedure was completed with no report of patient injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the tenaculum forceps instrument involved with this complaint and completed the device evaluation.Failure analysis investigations replicated and confirmed the customer reported complaint.Failure analysis found the primary finding of pitch cable broken to be related to the customer reported complaint.The instrument was found to have a broken pitch cable at the distal end.The broken cable segment that contains the crimp was missing from the clevis.Pitch cable breakage occurs when tensile load exceeds the ultimate strength of the material.The pitch cable construction is designed to optimize load an fatigue (cycling) characteristics.Variation in customer use condition procedure type, patient anatomy, product handling, instrument tip lengths, grip torque, and manufacturing tolerances are a few variables which can influence pitch cable failure.Additional observation unrelated to reportable finding: the instrument was found to have corrosion on one or more clamping pulleys in the backend.The root cause of corroded/ contaminated instrument clamping pulleys is typically attributed to mishandling/misuse, most commonly caused by improper cleaning/reprocessing techniques.No investigation required as no image or video clip for the reported event was submitted for review.A review of the instrument log for the tenaculum forceps instrument (part# 420207-10| lot/serial# (b)(4)) associated with this event has been performed.Per this review of the logs, the tenaculum forceps instrument was last used on (b)(6) 2022 via system serial# (b)(4).There were 5 uses remaining after this last usage.This complaint is being reported based on the following conclusion: this instrument is designed with two pitch cables, each with a crimp at the distal end.If a pitch cable breaks at the distal end, a cable segment and/or the crimp could fall into the patient.Although no patient harm occurred, if this malfunction were to recur it could likely cause or contribute to an adverse event.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: TENACULUM 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: 14960314
• Report Number: 2955842-2022-12845
• Device Sequence Number: 6896479
• Product Code: NAY
• UDI-Device Identifier: 00886874111659
• UDI-Public: (01)00886874111659(10)K10220104
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/08/2022

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: 420207-10
• Device Catalogue Number: 420207
• Device Lot Number: K10220104 182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2022
• Initial Report FDA Received Date: 07/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2022
• 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: Female