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.

Manufacturer Narrative

D02, d01, d11: intuitive surgical, inc.(isi) received the permanent cautery hook instrument involved with this complaint and completed the evaluation.The customer reported issue was replicated/confirmed.Failure analysis found the primary finding of the thermal damage at the weld on the monopolar yaw pulley to be related to the customer reported complaint.The distal assembly was disassembled in-house and the monopolar yaw pulley was found to have thermal damage at the weld.An electrical continuity test was performed and passed.The root cause of this failure was attributed to device design.Additional observations not reported by site that are related to the customer reported complaint were also identified.The permanent cautery hook instrument was found to have thermal damage on the conductor cap and the root cause of this failure was attributed to mishandling/misuse.The instrument was found to have a broken monopolar conductor wire at the weld when the distal assembly was disassembled.The instrument failed the electrical continuity test and the root cause of this failure is attributed to device design.The permanent cautery hook instrument was found to have damage of the conductor wire¿s insulation at the distal end.Thermal damage was observed on the instrument's insulation near the weld.Some internal wires were exposed due to the damage and the root cause of this failure was attributed to a component failure.A review of the instrument log for the permanent cautery hook (470183-14/n111099020034) associated with this event has been performed.Per logs, the permanent cautery hook instrument was last used on (b)(6) 2021 on system sk0029.The instrument had 8 uses remaining after the last procedural use.

Event Description

Refer to h10/h11 for follow-up information.

• 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
• UDI-Device Identifier: 00886874112311
• UDI-Public: (01)00886874112311(10)N11190902
• 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

• 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: N11190902 0034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2022
• Initial Date Manufacturer Received: 12/24/2021
• Initial Date FDA Received: 01/20/2022
• Supplement Dates Manufacturer Received: 01/27/2022
• Supplement Dates FDA Received: 02/22/2022
• 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 Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES.