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 02/16/2022

Event Type  malfunction  

Event Description

It was reported that prior to the start of a da vinci-assisted surgical procedure, the tenaculum forceps had wires sticking out.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) performed 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 associated with this complaint and completed its investigation.The failure analysis investigations replicated/confirmed the customer reported complaint "wires sticking out." 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 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 root cause of this failure is attributed to a component failure.An additional observation not reported by the site was also identified.The instrument was found to have various scratch marks with light material removed on the main tube.The scratch marks were 0.078¿ - 0.114 in length and were not aligned with the tube axis.The root cause of scratch marks /abrasions on the instrument main tube is typically attributed to mishandling/misuse.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 video clip for the reported event was submitted for review.A review of the site's system logs for the reported procedure date was conducted.Investigation revealed there were no related system errors to have occurred during the surgical procedure that would have likely caused or contributed to the reported complaint.However, the system log indicates the tenaculum forceps instrument associated with this event was last used in a procedure on (b)(6) 2022 on system (b)(4).The instrument had 1 life remaining.It is unknown if the damage to the instrument occurred during the last known usage, or later, such as during cleaning and sterilization.This complaint is reportable due to the following conclusion: failure analysis acknowledged that a fragment was missing from a portion of the device that enters the patient.Based on the information provided, there was no report from the customer that a fragment from the instrument fell into the patient during the procedure.While there was no report of harm or injury to a patient and no report of fragments falling into a patient, the reported failure mode could likely cause or contribute to an adverse event if the fragment(s) did fall into the patient.

• 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: 14035293
• MDR Text Key: 298393981
• Report Number: 2955842-2022-10911
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112366
• UDI-Public: (01)00886874112366(11)210624(10)N10210628
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/07/2022

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
• Device Operator: Health Professional
• Device Model Number: 470207-10
• Device Catalogue Number: 470207
• Device Lot Number: N10210628 0178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2022
• Initial Date Manufacturer Received: 03/07/2022
• Initial Date FDA Received: 04/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2021
• 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