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

Model Number 420207-09

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2021

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted myomectomy surgical procedure, the tenaculum forceps instrument cable was found to be damaged. The procedure was completed with no reported injury. Intuitive surgical, inc. (isi) followed up with the initial reporter and on 14-dec-2021, obtained the following additional information: the procedure occurred on (b)(6) 2021. No other information was available.

Manufacturer Narrative

Intuitive surgical, inc. (isi) received the tenaculum forceps involved with this complaint and completed the device evaluation. Failure analysis found the primary failure of severely bent grip tips to be related to the customer reported complaint. The instrument was found to have severely bent grips. The grip tips appeared to be crossed with one another at the distal end. As a result resistance was observed during manual articulation of the grip inputs. For clarification, the grip cables did not appear to be broken or damaged. The root cause of severely bent instrument grip tips is typically attributed to mishandling/misuse, such as excess force applied to the instrument jaws. Failure analysis found a secondary 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 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 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. The root cause of the broken pitch cable is attributed to a component failure and related to device design. A review of the site's complaint history does not show any additional complaints related to this product and/or this event. No image or procedure video was provided for review. A review of the instrument log for the tenaculum forceps instrument (part# 420207-09/lot# (b)(4)) associated with this event has been performed. Per logs, the instrument was last used for a procedure on (b)(6) 2021 using system sh0350. The instrument had 6 remaining usable lives with no subsequent use recorded. This complaint is being reported because 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. Blank mdr fields: follow-up was attempted, but the patient information in sections was either unknown, unavailable, not provided, or not applicable. The expiration date in section is not applicable. Field is blank because the product is not implantable. Information for the blank fields in section is not available. Fields are not applicable.

• Brand Name: ENDOWRIST;DAVINCI SI
• Type of Device: 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: 13102785
• MDR Text Key: 284864393
• Report Number: 2955842-2021-11830
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K050369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 420207-09
• Device Catalogue Number: 420207
• Device Lot Number: N10190715 409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2021
• Date Manufacturer Received: 12/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A

Patient Treatment Data

Date Received: 12/29/2021 Patient Sequence Number: 1

Treatment

DA VINCI INSTRUMENTS AND ACCESSORIES