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

Model Number 470183-14

Device Problems Break (1069); Failure to Deliver Energy (1211)

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

Event Date 03/11/2021

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.Failure analysis investigations replicated and confirmed the customer reported complaint "energy wasn't activated".Failure analysis found the primary failure of broken conductor wire at the proximal end to be related to the customer reported complaint.The instrument was found to have a broken conductor wire at the proximal end.The location of the break is where the conductor wire meets the connector pin.The instrument failed the electrical continuity test.No signs of thermal damage were observed.The root cause of this failure is attributed to manufacturing.A review of the device logs for the permanent cautery hook (part# 470183-14 | lot/serial# n10210104-0064) 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 9 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 bipolar 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 surgical procedure, the permanent cautery hook had no energy when activated.The customer used a backup instrument to continue.The procedure was completed with no reported injury.Follow-up was performed to obtain additional information related to the event.However, as of the date of this report, no further details have been received.

• Brand Name: ENDOWRIST
• 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: 11768015
• MDR Text Key: 268036362
• Report Number: 2955842-2021-10471
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112311
• UDI-Public: (01)00886874112311(11)201217(10)N10210104
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K131861
• 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: 04/07/2021

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: 470183-14
• Device Catalogue Number: 470183
• Device Lot Number: N10210104 0064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2021
• Initial Date FDA Received: 05/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2020
• 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