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

Model Number 470183-14

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 10/07/2021

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the permanent cautery hook instrument involved with this complaint and completed the device evaluation.Failure analysis confirmed the reported complaint.The instrument was found to have thermal damage on the monopolar yaw pulley.The yaw pulley showed signs of charring and localized melting at the base of the hook.The conductor wire was inspected and did not exhibit any signs of breakage or insulation damage.No thermal damage was observed on the conductor wire.An electrical continuity test was performed, and the instrument passed.The housing was removed from the back end, and no damage was observed.The root cause for the thermal damage on the yaw pulley weld is attributed to the device design.Additional observation not reported by site: the instrument was found to have a dislodged ceramic sleeve.No missing material was found.The ceramic sleeve is not cracked or broken.Due to the location of the thermal damage on the yaw pulley, the root cause of dislodged instrument ceramic sleeve is attributed to the device design.A review of the site's complaint history does not reveal any additional complaints involving this product and/or this event.A review of the instrument log for the permanent cautery hook instrument (part number: 470183-14, lot number: n11210426 0108) associated with this event has been performed.Per logs, the instrument was last used on (b)(6) 2021 on system sk2738.The instrument was used for 1 hour and 15 minutes.The instrument had 7 uses remaining out of 10 maximum tool uses.No image or video was provided for review.This complaint is being reported due to the following conclusion: failure analysis found evidence of thermal damage to the weld with no indication or claim of user mishandling or misuse.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.Blank mdr fields: 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.Fields pma/510(k) number and adverse event are not applicable.

Event Description

It was reported that during a da vinci-assisted cholecystectomy surgical procedure, the hook of the permanent cautery hook instrument broke.No fragment fell into the patient.The procedure was completed with no reported patient injury.Intuitive surgical, inc.(isi) followed up with the initial reporter (nurse) and obtained additional information: the instrument was inspected prior to use with no damages noted.There was no arcing event or instrument collision observed during the procedure.

• 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: 13370403
• MDR Text Key: 284609395
• Report Number: 2955842-2022-10128
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112311
• UDI-Public: (01)00886874112311(11)210422(10)N11210426
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2022
• 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: N11210426 0108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2021
• 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.