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

Model Number	420049-12
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy procedure, the cadiere forceps instrument's cable broke.The procedure was completed with no reported injury.The cadiere forceps is a multiple-use endoscopic instrument with a grasping tip to be used in conjunction with the da vinci system.The instrument is designed to grab, manipulate, retract, and dissect tissue during a da vinci assisted surgical procedure.Intuitive surgical, inc.(isi) followed up with the initial reporter for additional information; however, no response has been received at the time of this report.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the 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 broken pitch cable to be related to the customer reported complaint.The instrument was found to have a broken pitch cable at the distal clevis hub.The broken cable segment that contains the crimp was missing from clevis.The crimp measures approximately 0.032¿ x 0.046.Pitch cable breakage occurs when tensile load exceeds the ultimate strength the material.The pitch cable construction is designed to optimize load and fatigue (cycling) characteristics.Variation in customer use conditions, procedure type, patient anatomy, product handling, instrument tip lengths, grip torque, and manufacturing tolerances are a few variables which can influence pitch cable failure.An additional observation not reported by the site was also observed.The instrument was found to have various scratch marks removed on the main tube.The scratch marks were 0.075¿ - 0.276¿ in length and were not aligned with the tube axis.The root cause of the scratches is typically attributed to mishandling / misuse.Event verification confirmed that a pulmonary lobectomy surgical procedure was performed on (b)(6) 2022 on system sh1153.A review of the instrument log for the cadiere forceps instrument (pn# (b)(4) / lot# n10190311-916) associated with this event has been performed.Per logs, the instrument was last used on 05/20/2022 on system sh1153 for approximately 2hr 14min.The alleged event occurred on the 9th use of the instrument.A review of the site's complaint history does not reveal any related or duplicate complaints involving this product and/or this event.No image or video was provided for review.This complaint is reportable due to the following: 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.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.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: CADIERE 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: 15222719
• Report Number: 2955842-2022-13457
• Device Sequence Number: 20286539
• Product Code: NAY
• UDI-Device Identifier: 00886874111338
• UDI-Public: (01)00886874111338(10)N10190311
• 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,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/15/2022

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: 420049-12
• Device Catalogue Number: 420049
• Device Lot Number: N10190311 916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2022
• Initial Report FDA Received Date: 08/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2019
• 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 Age: 40 YR
• Patient Sex: Male