MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; PERMANENT CAUTERY HOOK

Model Number 420183-15

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 07/18/2021

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted hysterectomy surgical procedure, the customer discovered the wire on the permanent cautery hook instrument was broken.There was no report of any fragments falling inside the patient.The customer replaced the permanent cautery hook instrument with a back-up instrument of the same kind and completed the procedure with no reported injury.On 20-oct-2021 and 27-oct-2021, intuitive surgical, inc.(isi) obtained the following additional information regarding the reported event: the permanent cautery hook instrument was reportedly inspected prior to use, and no issues were noted.The operation was difficult, and there might have been an instrument collision at the time of the event.The permanent cautery hook instrument had a broken steel wire, and the cable was not damaged.It was confirmed that no fragments fell inside the patient during the procedure.There is no video recording of the procedure.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the permanent cautery hook instrument involved with this complaint and completed the device evaluation.Failure analysis investigations replicated/confirmed the customer reported complaint.Failure analysis found the primary failure of the 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.There was no material missing from the instrument.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 was attributed to a component failure and related to device design.Failure analysis investigations performed additional tests on the instrument.Visual inspection of the conductor wires and insulation found no physical or cosmetic damage.An electrical continuity test was performed and passed.No functional test could be performed on an in-house system due to the cable breakage.A review of the logs showed the permanent cautery hook instrument (part# 420183-15 / lot# n10210125-899) was last used on (b)(6) 2021 during a procedure with system (b)(4).The permanent cautery hook instrument has 10 allotted uses and had 7 uses remaining.Based on this review, the permanent cautery hook instrument was used in subsequent procedures after the alleged event reported on this record.In addition, 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 to isi for review.This complaint is being reported due to the following conclusion: the permanent cautery hook 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 inside 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 information for the patient-related fields was either unknown, unavailable, or not provided.The expiration date is not applicable.Field is blank because the product is not implantable.Information for the blank fields is not available.Fields are not applicable.

• Brand Name: ENDOWRIST;DAVINCI SI
• Type of Device: PERMANENT CAUTERY HOOK
• 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: 13083700
• MDR Text Key: 286863541
• Report Number: 2955842-2021-11809
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874111536
• UDI-Public: (01)00886874111536(10)N10210125
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420183-15
• Device Catalogue Number: 420183
• Device Lot Number: N10210125 899
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Date Manufacturer Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2021
• 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