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

Model Number 420183-11

Device Problem Arcing (2583)

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

Event Date 04/11/2018

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc (isi) received the instrument involved with this complaint and completed the device evaluation.Failure analysis confirmed the customer reported failure.The distal clevis ear was cut off to inspect conductor wire to yaw pulley interface.Visual inspection showed evidence of thermal damage on the yaw pulley near the wire interface.Silicone potting was observed to slightly be separated from the yaw pulley, leaving a segment of bare wire exposed.Additionally, the conductor wire detached from the yaw pulley easily when using tweezers to pull on the wire, indicating a broken wire where it gets welded to the hook shank.Broken wire at the weld combined with silicone potting separation likely created a path for arcing to occur, which confirms the customer reported complaint.Wire breakage at weld is a known issue which is not attributed to mishandling/misuse engineering has determined that the failure related to this complaint, the conductor wire pulling out from the weld location at the base of the instrument, is not user interaction related.The customer reported complaint does not itself constitute an mdr reportable event; however, the charring damage found during failure analysis suggests that unintended arcing occurred.Although, no patient harm was reported, if the malfunction were to recur it could cause or contribute to an adverse event.

Event Description

It was reported that during a da vinci-assisted surgical procedure, arcing was noted from the permanent cautery hook instrument.The planned surgical procedure was completed and no patient harm, adverse outcome or injury was reported.

• Brand Name: ENDOWRIST;DAVINCI SI
• Type of Device: PERMANENT CAUTERY HOOK
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• Manufacturer Contact: tabitha reed ; 950 kifer rd.; sunnyvale ; 4085232100
• MDR Report Key: 7648276
• MDR Text Key: 112895060
• Report Number: 2955842-2018-10333
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874111536
• UDI-Public: (01)00886874111536(10)N11160719
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420183-11
• Device Lot Number: N11160719 757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2016
• 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