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

Model Number 420183-10

Device Problems Break (1069); Material Split, Cut or Torn (4008)

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

Event Date 01/21/2021

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the permanent cautery hook involved with this complaint and completed the device evaluation.Failure analysis investigations replicated and confirmed the customer reported complaint "broken cables." failure analysis found the primary finding of conductor wire broken to be related to the customer reported complaint.For clarification, the instrument was found to have a broken conductor wire at the distal end.The root cause of this failure is attributed to a component failure.A review of the device logs for the permanent cautery hook (part# 420183-10 | lot/serial# (b)(4)) associated with this event has been performed.Per this review of the logs, the permanent cautery hook was last used on (b)(6) 2021 via system serial# (b)(4).There were 2 uses remaining after this last usage.This last usage of the device per the log review matches the reported event date, indicating that the instrument was not used after the date of the reported event.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 available for review.A system log review was performed, but no errors related to this event would exist in the logs.Based on the information provided at this time, this complaint is being reported because the permanent cautery hook instrument had conductor wire damage with no evidence or claim of user mishandling or misuse.While there was no harm or injury to the patient, the reported failure mode could potentially 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 permanent cautery hook instrument would not move and had broken cables.The customer used a backup instrument of the same kind to continue.The procedure was completed with no reported harm, injury, or adverse outcome.Intuitive surgical, inc.(isi) performed follow-up with the customer to request additional information about the event.However, as of the date of the report, no further details have been provided.

• 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: david wang ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 11490526
• MDR Text Key: 243910673
• Report Number: 2955842-2021-10254
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874111536
• UDI-Public: (01)00886874111536(10)M10141126
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K050369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420183-10
• Device Catalogue Number: 420183
• Device Lot Number: M10141126 708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2014
• 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