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

Model Number 470183-14

Device Problem Smoking (1585)

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

Event Date 06/04/2019

Event Type  malfunction  

Manufacturer Narrative

Isi received the permanent cautery hook instrument involved with this complaint and completed the device evaluation.Failure analysis confirmed the reported issue and found thermal damage at the weld joint of the yaw pulley once a side of the clevis ear was removed for further investigation.The silicone potting was noted to be compromised and conductor wire damage was noted near the weld location.The instrument failed an electrical continuity test.When the conductor wire was exercised on the distal end, it detached from the yaw pulley, which suggests that the wire broke at the weld location.It was noted that the silicone potting damage may have allowed for excess movement of the wire at the yaw pulley exit, which may have increased fatigue stress on the wire.No signs of user mishandling/misuse were noted.Based on the information provided at this time, this complaint is being reported because the permanent cautery hook instrument 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 surgical procedure, a permanent cautery hook instrument was "smoking on the connection part between the arm and tip." the procedure was completed with a backup instrument and there was no reported harm, injury, or adverse outcome.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instruments and accessories were inspected prior to use.No post-surgical complications occurred.

• 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: 8841758
• MDR Text Key: 152662417
• Report Number: 2955842-2019-10572
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: KR
• PMA/PMN Number: K131861
• 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
• Report Date: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470183-14
• Device Lot Number: N10181219 0022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2018
• 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