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

Model Number 470183-14

Device Problems Thermal Decomposition of Device (1071); Fracture (1260); Smoking (1585)

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

Event Date 02/11/2021

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 confirmed the customer reported complaint of "insulation faults at the end of the hook - smoke comes out of the tool." upon cutting a distal clevis ear for inspection of the interior components at the distal end, failure analysis found the primary failure of conductor wire broken at weld to be the cause of the customer reported complaint.As a result of the breakage at the weld, the monopolar yaw pulley and conductor wire cap had incurred thermal damage near the weld location.Root cause of the breakage is attributed to device design.The instrument was also found to have the cautery hook dislodged from the monopolar yaw pulley base, possibly due to the weld breakage and subsequent thermal damage at the hook base.The hook was partially sticking out and was able to be removed from the yaw pulley completely by hand.The hook was not found broken.Additional observations not reported by site: the instrument was found to have indentations on the edges of the distal idler pulleys, which is attributed to mishandling via instrument collisions.The instrument was found to have various scratch marks with light material removed on the main tube.The scratch marks were 0.022¿ - 0.278" in length and were not aligned with the tube axis.Root cause is attributed to mishandling/misuse.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.A review of the instrument log for the permanent cautery hook instrument (part# 470183-14/n11200601-0109) associated with this event has been performed.Per this review of the logs, the instrument was last used on (b)(6) 2021 on system sk4043, with 6 uses remaining.This complaint is being reported based on the following conclusion: the permanent cautery hook instrument smoked, had incurred thermal damage, and was found to have a broken conductor wire at the weld with no evidence or claim of user mishandling or misuse.While there was no report of patient involvement, the initial reported complaint and subsequent failure analysis findings are indicative of a failure mode that could likely cause or contribute to an adverse event if it were to recur.Follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.Implant date is blank because the product is not implantable.Information for the blank fields in initial reporter is not available.Pma/510(k) number, adverse event, recall number, and correction/removal report number are not applicable.

Event Description

It was reported that during central processing, insulation faults were identified at the end of the permanent cautery hook instrument.It was also noted that smoke came out of the instrument.There was no report of patient involvement.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: david wang ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 11490498
• MDR Text Key: 239975049
• Report Number: 2955842-2021-10253
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112311
• UDI-Public: (01)00886874112311(10)N11200601
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/17/2021

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: 470183-14
• Device Catalogue Number: 470183
• Device Lot Number: N11200601 0109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Date Manufacturer Received: 02/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2020
• Is the Device Single Use?: Yes
• 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.