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

Model Number	420207-10
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during central processing, that the tenaculum forceps had a broken cable.There was no report of patient involvement.The tenaculum 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.An attempt has been made to obtain additional information from the customer concerning the reported event with no success.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the tenaculum forceps associated with this complaint and completed its investigation.Failure analysis (fa) confirmed the reported issue the instrument was found to have a broken pitch cable at the distal end.The broken cable segment that contains the crimp was still installed in 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.Fa noted this issue is attributed to a component failure.Additionally, the instrument was found to have one release lever dislodged.The lever was returned with the instrument and fa attributed this issue to mishandling/misuse.A review of the logs was performed.Per the review, the instrument was last used on: system serial - (b)(4), event date - (b)(6) 2022, and procedure name - myomectomy a review of the site's complaint history does not show any additional complaints related to this product and/or this event.This complaint is considered a reportable malfunction due to 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.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: 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: 14796520
• Report Number: 2955842-2022-12363
• Device Sequence Number: 4831982
• Product Code: NAY
• UDI-Device Identifier: 00886874111659
• UDI-Public: (01)00886874111659(10)N10211004
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/24/2022

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: N10211004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2021
• 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