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

Model Number 420183-15

Device Problem Smoking (1585)

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

Event Date 12/15/2021

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted myomectomy surgical procedure, the permanent cautery hook (pch) instrument was found to have smoke generated from behind and not from the instrument tip.A backup instrument was used to continue the procedure.There was no report of fragments 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 observed.There was no patient injury/harm.The customer confirmed that no fragment fell inside of the patient.The instrument was in use for cauterizing for about 10 minutes, then smoke was generated from behind the instrument tip.Arcing was not observed.Monopolar coagulation energy was activated with a 3rd party generator.The settings used on the generator was 50 for cutting and 50 for coagulation.The monopolar cord was not connected to a bipolar instrument.In addition, the instrument tips did not collide with any other instrument or tool during procedure.The instrument tips were not in contact with tissue and did not touch any staples, clips or sutures.The jaws were not immersed in liquid or contaminated by carbonized tissue (bio debris) prior to activating the instrument.The instrument was not removed at any time.The patient has not returned to the hospital due to any post-surgical complications.Photographic images of the device or a video recording of the procedure were not available for isi review.Although requested, the following information is unknown: if the cannula was inspected prior to use, if other instruments were in use, and what caused the event along with information regarding patient demographics, relevant testing, and medical history.

Manufacturer Narrative

Intuitive surgical, inc.(isi) has not 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.In addition, a review of the instrument log for the permanent cautery hook (pch) (part # 420183-15/lot# n10210531 039) 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 6 uses remaining after last use.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 smoked with no evidence or claim of user mishandling or misuse.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

Intuitive surgical, inc.(isi) received the permanent cautery hook instrument involved with this complaint and completed the device evaluation.Failure analysis investigations replicated and confirmed the customer reported complaint "during a procedure, smoke generator behind, not at the tip.¿ failure analysis found the primary failure of thermal damage and melted tip to be related to the customer reported complaint.During visual inspection, the instrument was found to have thermal damage at the tip.The sealant at the base had melted causing the cautery insulator to separate from the base and to rest on the tip of the hook.The instrument passed electric continuity.The instrument was placed and driven on an in-house system.The instrument passed the recognition an engagement tests.The settings used on the generator was 50 for cutting and 50 for coagulation to match the settings stated in the complaint.The instrument released energy and began arcing almost immediately on several attempts.Inspection of the silicone potting and conductor wire weld to hook/spat base was performed by cutting distal clevis and removing conductor cap.The conductor wire was not broken and was still attached to the yaw pulley.Additional observation(s) related to customer reported complaint was that visual inspection revealed the instrument had thermal damage to the distal clevis, and proximal clevis.Root cause is attributed to user mishandling/misuse.Visual inspection revealed a related finding of thermal damage to the idler pulleys.The root cause was attributed to device design.

• Brand Name: ENDOWRIST;DAVINCI SI
• 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: 13318273
• MDR Text Key: 284214864
• Report Number: 2955842-2022-10111
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874111536
• UDI-Public: (01)00886874111536(10)N10210531
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K050369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/28/2021

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: 420183-15
• Device Catalogue Number: 420183
• Device Lot Number: N10210531 0039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/28/2021
• Initial Date FDA Received: 01/21/2022
• Supplement Dates Manufacturer Received: 01/27/2022
• Supplement Dates FDA Received: 02/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2021
• 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
• Patient Sex: Female