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

Model Number 420183-12

Device Problems Smoking (1585); Arcing (2583)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/16/2019

Event Type  malfunction  

Manufacturer Narrative

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.This complaint is being reported due to the following conclusion: it was alleged that during a da vinci-assisted cholecystectomy procedure, the permanent cautery hook instrument arced, smoked, and had conductor wire damage with no evidence or claim of user mishandling or misuse.

Event Description

It was reported that during a da vinci-assisted cholecystectomy procedure, a cable of the permanent cautery hook instrument was found to be loose and "flames" were noted when cautery energy was activated.No fragments fell inside the patient.The procedure was completed with no reported adverse effect, harm, or outcome to the patient.Intuitive surgical, inc.(isi) contacted the site and obtained additional information regarding the reported issue: the instrument was inspected prior to use.While the surgeon was starting to dissect tissue and clarify anatomy around the gallbladder neck, a small flame and smoke were visible from the conductor wire of the instrument.The instrument was immediately removed so there was no burn to the patient's tissue.The surgeon was also using a fenestrated bipolar forceps instrument, but no collisions were noted during the case.It was unknown which type of energy was being activated at the time of the event.The customer was using a covidien valleylab ft10 electrosurgical unit (esu), which was set at 25 for cut and coagulation.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the permanent cautery hook instrument involved with this complaint and completed the device evaluation.Failure analysis investigation was able to replicate/confirm the reported issue.The instrument conductor wire was exposed on the outside of the yaw pulley.The distal clevis ear was cut off to inspect the conductor wire and found the conductor wire broken at the weld.No thermal damage was found on the yaw pulley.The instrument was found to have thermal damage on the conductor wire cap.The specific failure mode and the associated device component is a broken conductor wire at the weld.Additionally, the instrument was found to have damage of the conductor wire¿s insulation.Thermal damage appears to have originated from the wire to yaw pulley interface as a result of the broken conductor wire at the weld.The bottom half of the silicone potting around the conductor wire is removed, possibly burned off as a result of the thermal damage.Regarding the damage to the conductor wire¿s insulation, the location of wire insulation damage is approximately where the edge of the conductor cap made contact with the dislodged wire.It is possible the insulation became damaged by rubbing against the edge of the cap.

Event Description

Refer to additional manufacturer narrative and/or corrected data.For follow-up information.

• Brand Name: ENDOWRIST
• Type of Device: PERMANENT CAUTERY HOOK
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale CA 94086
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale CA 94086
• Manufacturer Contact: izabel nielson ; 950 kifer rd.; sunnyvale, CA 94086 ; 4085232100
• MDR Report Key: 8722853
• MDR Text Key: 148790731
• Report Number: 2955842-2019-10472
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874111536
• UDI-Public: (01)00886874111536(10)N10170803
• Combination Product (y/n): N
• Reporter Country Code: SE
• PMA/PMN Number: K050369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420183-12
• Device Lot Number: N10170803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES