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 06/15/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted nephrectomy procedure, the user observed that the permanent cautery hook instrument tip "was burned" during intraoperative use.The instrument was replaced with a backup instrument.No fragment fell inside the patient.The customer completed the procedure with no other issue reported.Intuitive surgical, inc.(isi) followed up with the site and obtained the following additional information regarding the reported event: the instrument was inspected prior to use and there wasn¿t any damage or anything out of the ordinary.The instrument did not collide with any other instrument or tool during the procedure.No arcing was observed during the procedure.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the permanent cautery hook instrument involved with this complaint and completed the device evaluation.The reported event was confirmed through failure analysis investigation.Inspection found thermal damage on the monopolar yaw pulley.The conductor wire and its insulation was inspected and no damage was confirmed.The instrument was subjected to testing and passed self-test and the electrical continuity.The known cause of the issue is attributed to mishandling and 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 lot# n10210120 / sequence 0075 associated with this event has been performed.Per logs, the instrument was last used for a procedure on (b)(6) 2022 using system sk4412.No logged usage on the reported event date of (b)(6) 2022 on system sk4412.No subsequent use recorded after (b)(6) 2022.A review of the submitted image was performed by an intuitive surgical, inc.(isi) failure analysis engineer (fae).The following additional information was provided: the image suggests thermal damage to the yaw pulley and distal clevis of the permanent cautery hook instrument.This complaint is considered a reportable malfunction due to the following conclusion: it was alleged that the instrument exhibited signs indicative of thermal damage.Image analysis of the isi fae identified thermal damage to the yaw pulley and distal clevis of the permanent cautery hook instrument.Evaluation be fa confirmed thermal damage at the monopolar yaw pulley due to mishandling and 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 in was either unknown, unavailable, not provided, or not applicable.Device expiration date was left blank as this instrument has 10 usages allotted to it, which are tracked by the da vinci surgical system.The instrument has 3 remaining usable lives, therefore, had not expired.Field is blank because the product is not implantable.Information for the blank fields is not available.Fields are not applicable.

• 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: 15036625
• MDR Text Key: 296040920
• Report Number: 2955842-2022-13010
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112311
• UDI-Public: (01)00886874112311(11)210120(10)N10210120
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2022
• 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: N10210120 0075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2022
• Date Manufacturer Received: 06/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2021
• 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