MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; VESSEL SEALER EXTEND

Model Number 480422-01

Device Problem Failure to Deliver Energy (1211)

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

Event Date 10/29/2018

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.Failure analysis investigation confirmed the reported complaint of failed to operate when inserted.For clarification, the electrical continuity test failed.As a result, the energy function of the instrument was not working when activated on the system.No steam generation was observed when the energy pedal was activated while the grips were holding a wet towel.Further testing indicated the conductor wire was most likely broken at the weld location to the electrode.The root cause of the breakage is unclear since the conductor wire cannot break internally due to external mishandling.Based on the information provided, this event is being reported due to the following conclusion: the energy function and weld damage found during failure analysis suggest that sealing issues could occur.Although, no patient harm, adverse outcome or injury was reported, 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 total hysterectomy surgical procedure, the vessel sealer extend instrument failed to operate when inserted.After multiple tries, the customer opened a new instrument and inserted it onto the system.The new vessel sealer extend worked correctly.The planned surgical procedure was completed with no patient harm, adverse outcome, or injury reported.

• Brand Name: ENDOWRIST
• Type of Device: VESSEL SEALER EXTEND
• 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: 8204864
• MDR Text Key: 131779372
• Report Number: 2955842-2018-10793
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874115661
• UDI-Public: (01)10886874115661(17)200630(10)T10180604
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 480422-01
• Device Lot Number: T10180604 0114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2018
• Date Manufacturer Received: 12/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1