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

Model Number 470183-14

Device Problems Thermal Decomposition of Device (1071); Arcing (2583); Sparking (2595); Material Split, Cut or Torn (4008)

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

Event Date 10/11/2021

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted distal "pancreteactomy" 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 not yet received the permanent cautery hook instrument 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 site's complaint history does not show any additional complaints related to this product and/or this event.No image or video was provided.A review of the instrument log for the permanent cautery hook instrument lot# n11200713 / sequence (b)(4) associated with this event has been performed.Per logs, no recorded usage on the reported event date of (b)(6) 2021 on system (b)(4).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 3 remaining usable lives with no subsequent use recorded.This complaint is being reported due to the following conclusion: it was alleged that the instrument sparked during a procedure.The allegation could be related to the potential for electrical discharge at a location other than intended.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.

Manufacturer Narrative

Updated information can be found in the following fields: d9, d10, g3, g6, h2, h3, h6 and h10.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.D02, d11 - intuitive surgical, inc.(isi) received the permanent cautery hook instrument involved with this complaint and completed the device evaluation.Failure analysis investigation identified conductor wire insulation damage near the yaw pulley exit, exposing the bare wire and causing thermal damage around the surrounding area.Insulation material approximately 0.10¿ x 0.03¿ was missing from the conductor wire.The instrument passed electrical continuity testing.This observation is attributed to a component failure.The instrument was further inspected and thermal damage to the distal clevis was confirmed.The affected areas exhibited char marks.Any material missing from the damage of the distal clevis is likely thermally induced rather than mechanically induced.The secondary finding is related to the damaged conductor wire insulation.The root cause of the secondary failure was determined to be related to user mishandling/misuse.

Event Description

Refer to h10/h11 for follow-up 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: 13543804
• MDR Text Key: 296347673
• Report Number: 2955842-2022-10259
• 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

• Date FDA Received: 02/16/2022
• 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: N11200713 0174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 02/23/2022
• 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