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 02/01/2019

Event Type  malfunction  

Manufacturer Narrative

Isi received the instrument involved with this complaint and completed the device evaluation.Failure analysis investigation was able to confirm the reported issue.The instrument was found to have a broken conductor wire at the weld joint of the yaw pulley after one side of the clevis ear was removed for further investigation.The silicone potting area appeared to be compromised and the conductor wire was damaged around the weld location.Additional observation not reported was that the instrument was found to have thermal damage of the monopolar yaw pulley.Black char marks were observed at the weld joint.The complaint is being reported due to the following conclusion: during a da vinci-assisted pancreatectomy procedure, the permanent cautery hook instrument smoked and had conductor wire damage with no evidence or claim of user mishandling or misuse.While there was no report of any patient harm, adverse outcome, or injury, recurrence of the reported failure mode could cause or contribute to an adverse event.

Event Description

It was reported that during a da vinci assisted pancreatectomy (whipple) procedure, the cautery cable near the tip of the permanent cautery hook instrument was "smoking" during energy application.The procedure was completed with no reported injury to the patient.Intuitive surgical, inc.(isi) contacted the initial reporter and obtained additional information regarding the reported issue: arcing was observed during the procedure.The instrument was brand new, so it was not inspected prior to use.When the issue occurred, the surgeon was activating monopolar coagulation energy.A fenestrated bipolar forceps instrument and cadiere forceps instrument were also in-use; however, there were no collisions.The customer was using a valleylab force fx electrosurgical unit (esu) with a cut and coagulation power setting of 40.

• 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: pat flanagan ; 950 kifer rd.; sunnyvale, CA 94086 ; 4085232100
• MDR Report Key: 8362840
• MDR Text Key: 136902527
• Report Number: 2955842-2019-10127
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874111536
• UDI-Public: (01)00886874111536(10)N10180413
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K050369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/01/2019

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: 420183-12
• Device Lot Number: N10180413 673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Initial Date Manufacturer Received: 02/01/2019
• Initial Date FDA Received: 02/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES