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

Model Number 470207-10

Device Problem Material Fragmentation (1261)

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

Event Date 11/17/2021

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the tenaculum forceps instrument and performed a device evaluation.Failure analysis confirmed the customer reported issue.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 the clevis, the crimp measures approximately 0.032¿ x 0.046".The clevis did not exhibit any damage or wear marks.The root cause of the issue identified through failure analysis was attributed to a component failure.A review of the device logs for the tenaculum forceps (470207-10 | n10200831 0020) associated with this event has been performed.Per this review of the logs, the tenaculum forceps was last used on (b)(6) 2021 via system serial# (b)(4), with 7 uses remaining.A review of the site's complaint history does not show any additional complaints related to this product.No image or procedure video was provided for review.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 patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.

Event Description

It was reported that during a da vinci-assisted myomectomy surgical procedure, the instrument ceased responding to the surgeon's control.The procedure was completed as planned with no report of patient harm, adverse outcome or injury.Intuitive surgical, inc.(isi) has performed follow-up to request additional information related to the reported event.However, as of the date of this report, no further details have been received.

Manufacturer Narrative

On 20-apr-2022, the following additional information was obtained: no fragment fell in the patient.The tenaculum forceps was in use at the time when it malfunctioned.There was a large 20 week size fibroid uterus.The tenaculum forceps was doing well to the point where it no longer was able to close and grasp the tissues.No reports of any fragment within the patient.No return to hospital.Patient followed up in clinic, she is doing really well and been discharged.No fragments fell within the patient.The following patient demographics were provided: 1.A.Age: 37 years.B.Date of birth: on (b)(6) 1987.C.Gender: female.D.Weight and unit (lbs/kgs): 48 kg.2.Please provide any relevant tests, results, and the date performed.Mri on (b)(6) 2021.3.Please provide any relevant patient history, including pre-existing medical conditions.Large fibroid uterus measuring approx.20 week pregnant size.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST
• 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: 14054832
• MDR Text Key: 298493507
• Report Number: 2955842-2022-10945
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112366
• UDI-Public: (01)00886874112366(10)N10200831
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470207-10
• Device Catalogue Number: 470207
• Device Lot Number: N10200831 0020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2020
• 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 Age: 37 YR
• Patient Sex: Female
• Patient Weight: 48 KG