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

Model Number 420207-10

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 03/21/2022

Event Type  Injury  

Manufacturer Narrative

Isi has not received the tenaculum forceps for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if additional information is obtained.A system log review confirmed the procedure date of (b)(6) 2022 on system sh1381.However, instrument log review of the product related to the complaint cannot be performed at this time because the batch lot number was incomplete.A review of the site's complaint history identified no other complaints related to the instrument and/or this event.No image or procedure video was provided for review.Based on the information available at this time, this complaint is being classified as a reportable event due to the following conclusion: it was alleged that the instrument broke and a fragment fell inside the patient during a da vinci assisted procedure.The fragment was retrieved during the same procedure with no patient injury.At this time it is unknown what caused the breakage to occur.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 as unintended fragment(s) falling into the patient may require surgical intervention.Follow-up was attempted, but patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.The product is not implantable.It is unknown if the initial reporter submitted a report to the fda.

Event Description

It was reported that during a da vinci-assisted myomectomy surgical procedure, wire of tenaculum forceps instrument was broken into the patient.The fragment was retrieved during the same procedure and was completed with no reported injury.Intuitive surgical, inc.(isi) made multiple follow up attempts to obtain additional information.However, no further details have been received as of the date of this report.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the tenaculum forceps instrument involved with this complaint and completed the device evaluation.Failure analysis investigation revealed that the instrument was found to have a broken pitch cable at the distal end.The broken cable segment that contains the crimp was not 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.Additional observation(s) not reported by site: the instrument was found to have a frayed grip cable at the distal end.The frayed cable strands stuck out at the wrist.The root cause of frayed - distal instrument grip cables is attributed to a component failure.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 the user, common.The instrument was found to have a dislodged grip cable at the proximal end.The yaw motion may be non-intuitive as a result.Root cause is attributed to a component failure.A review of the instrument log for the tenaculum forceps (420207-10/ n10190520-075) associated with this event has been performed.Per instrument was last used on 03/21/2022 on system (b)(4).The device has 0 uses remaining after last use.

• 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: 14247681
• MDR Text Key: 294173048
• Report Number: 2955842-2022-11315
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874111659
• UDI-Public: (01)00886874111659(10)N10190520
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420207-10
• Device Catalogue Number: 420207
• Device Lot Number: N10190520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2019
• 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 Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Female