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 03/21/2022

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc. (isi) has not received the permanent cautery hook for evaluation. Therefore, the root cause of the customer reported failure mode has not been determined. A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received. A review of the instrument log for the permanent cautery hook (pch) (part # 470183-14/lot# k12211110 0153) associated with this event has been performed. Per logs, the instrument was last used on (b)(6) 2021, on system (b)(4). The instrument had 7 uses remaining after last use. In addition, a review of the site's complaint history does not show any additional complaints related to this product and/or this event. No image or video clip for the reported event was submitted to isi for review. This event is being reported because the permanent cautery hook instrument exhibited signs indicative of thermal damage. At this time, it is unknown what caused the thermal damage to occur. 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.

Event Description

It was reported that during a da vinci-assisted pancreaticoduodenectomy surgical procedure, the customer was trying to remove the permanent cautery hook (pch) instrument after using the monopolar energy. However, the instrument tip could not be straightened and was removed with the trocar. Although the customer set the same energy power and only used monopolar energy, the yellow plastic part was melted. There was no report of fragment(s) falling inside the patient. The procedure was completed with no report of patient injury. Intuitive surgical, inc. (isi) followed up with the initial reporter and obtained the following additional information: the instrument was inspected prior to use with no damage found. The customer only used the permanent cautery hook (pch) instrument for dissecting the gallbladder at the time of the event. No other instruments were involved. The customer used if for 5 seconds each on the first and second uses and less than 10 minutes on the third use. The issue was identified after the customer finished the use of the instrument, so no back up instrument was needed. It was confirmed that no arcing was observed. The customer successfully removed the instrument with the trocar. The monopolar cord was not connected to a bipolar instrument. The settings used on the bovie generator was 6 for cutting and 6 for coagulation. In addition, the jaws were not immersed in liquid or contaminated by carbonized tissue (bio debris) prior to activating the instrument. The instrument tip(s) did not touch any staples, clips or sutures while energized. The instrument tips did not collide with any other instrument or tool during procedure. The patient had no injury/ harm and has not returned to the hospital. It was unknown if the cannula was inspected prior to use and what caused the event. Photographic images of the device(s) or a video recording of the procedure were not available for isi review. Information regarding patient relevant testing, and medical history were requested; however, the reporter was not able to provide that 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: 14149479
• MDR Text Key: 289598325
• Report Number: 2955842-2022-11137
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional

Reporter Occupation

• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• 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: K12211110 0153
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2021
• 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 Treatment Data

Date Received: 04/19/2022 Patient Sequence Number: 1

Treatment

DA VINCI INSTRUMENTS AND ACCESSORIES