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

Model Number 470183-14

Device Problems Arcing (2583); Sparking (2595)

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

Event Date 11/01/2021

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted distal pancreatectomy surgical procedure, the user observed that the permanent cautery hook instrument sparked during intraoperative use.The user completed the procedure using the backup instrument with no further issue reported.No fragment fell inside the patient.No known impact or patient consequence was reported.

Manufacturer Narrative

Intuitive surgical, inc.(isi) has requested that the permanent cautery hook instrument be returned for failure analysis to be performed, but the instrument has not yet been received.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 instrument (lot # n11200713 / sequence 0116) associated with this event has been performed.The logs show no usage on the reported event date, but follow-up to clarify has not been successful.The logs indicated that the instrument was used thrice.First on (b)(6) 2021, 2nd on (b)(6) 2021 and was last used on (b)(6) 2021 all on system (b)(4).The instrument has 7 remaining usable lives with no subsequent use recorded.A review of the site's complaint history shows additional complaint related to this product.A mdr has been submitted under patient identifier (b)(6) which states site had a similar issue with the permanent cautery hook instrument (lot # n11200713 / sequence 0116) for a procedure performed on (b)(6) 2021.No image or procedure video was provided for review.The permanent cautery hook (pch) is intended to be used with the da vinci system for precise dissection and division of tissue with monopolar cautery.The instrument is designed to provide energy from the designated location on the instrument (the tip) to the planned anatomical location when used as intended.The energy is activated by pressing the designated pedal on the surgeon side console (ssc).The instructions for use provides a warning: always inspect the instrument and instrument tip for abnormalities before use.Do not use the instrument if any abnormalities are observed.This complaint is considered a reportable malfunction due to the following conclusion: it was alleged that the instrument sparked.The allegation could be related to the potential for electrical discharge at a location other than intended.Based on the site history review, the customer was already aware of an instrument malfunction for a procedure performed on (b)(6) 2021 and this has been communicated to the manufacturer (isi) and an mdr report was submitted through patient identifier (b)(6) on (b)(6) 2021.Despite having knowledge of the instrument issue, the information suggests that the customer continued to reuse the instrument for subsequent procedures and this is considered intentional misuse of the product.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

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Failure analysis information can be found in h6 and h10.Intuitive surgical, inc.(isi) followed up with the site and obtained the following additional information regarding the reported event on (b)(6) 2022: the hospital nurse could not remember the exact date and time of the issue.The site indicated that an instrument inspection prior to use is always performed.At the time of the event, the instrument initially worked and an issue towards the middle part of the procedure was observed.The instrument arced during intraoperative use.The target tissue was not damaged.Initial information indicated ¿it is very shocked¿ and follow up clarified that the reporter meant that due to the issue surgeon felt very bad and shocked.D14 - intuitive surgical, inc.(isi) received the permanent cautery hook instrument involved with this complaint and completed the device evaluation.The reported event was not confirmed through failure analysis investigation.The instrument was tested with an in-house system and passed both the engagement and self tests.Testing found the instrument exhibiting intuitive motion in all directions with the grips properly opening and closing.The energy delivery functionality was verified and passed specification.No unintended energy or inadvertent arcing occurred.No instrument damage was identified.Review of the system logs identified no related error.The instrument operated as expected.

• 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: 13550812
• MDR Text Key: 296383980
• Report Number: 2955842-2022-10261
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112311
• UDI-Public: (01)00886874112311(10)N11200713
• 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,Followup
• Report Date: 01/24/2022

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: N11200713 0116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 01/24/2022
• Initial Date FDA Received: 02/17/2022
• Supplement Dates Manufacturer Received: 02/23/2022
• Supplement Dates FDA Received: 03/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2020
• 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