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

Model Number 470183-14

Device Problems Smoking (1585); Arcing (2583); Sparking (2595)

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

Event Date 12/13/2021

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc. (isi) has requested the 8mm permanent cautery hook instrument involved with this complaint to be returned for failure analysis. However, as of the date of this report, the instrument has not been received. A review of the site's complaint history does not show any additional complaints related to this product. Verification of the event details via instrument logs cannot be performed at this time because there is insufficient product information - the instrument sequence number was not provided. No image or video of the procedure was provided for review. Based on the information provided at this time, this complaint is being classified as a reportable event due to the following conclusion: the permanent cautery hook instrument reportedly had sparks & smoke arising from the wrist of the instrument whenever the energy pedals were pressed, with no evidence or claim of user mishandling/misuse. At this time the root cause of the reported damage is unknown as the instrument has not been returned for evaluation. Although there was no report of patient injury, the issue 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 8mm permanent cautery hook instrument had sparks & smoke arising from the wrist of the instrument whenever the energy pedals were pressed. The procedure was completed with no reported injury. Intuitive surgical, inc. (isi) made multiple follow-up attempts to obtain additional information. However, no further details have been received as of the date of this report.

• 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: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 13303846
• MDR Text Key: 284099279
• Report Number: 2955842-2022-10101
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K131861
• 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,Followup
• Report Date: 12/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 470183-14
• Device Catalogue Number: 470183
• Device Lot Number: N11190902 0034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2022
• Date Manufacturer Received: 01/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2019
• 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 Treatment Data

Date Received: 01/20/2022 Patient Sequence Number: 1

Treatment

DA VINCI INSTRUMENTS AND ACCESSORIES