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

Model Number	480322-07
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.Failure analysis could not confirm the customer reported failure.The instrument was placed on an in-house system for the sealing test and the self-test passed and energy delivered without any issues.The electrical continuity test passed.However, the instrument was found to have a dislodged electrode at the distal end.It is unclear what caused the electrode to pull out of the over molded jaw.The jaws had heavy bio debris buildup, however, internal testing has not shown this build up to be the root cause of the electrode dislodged failure.Based on the information provided, this event is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, the vessel sealer instrument would not provide sufficient energy to seal the tissue.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 or Problem Description
It was reported that during a da vinci-assisted total benign hysterectomy procedure, the vessel sealer instrument stopped sealing.There was no report of patient harm, adverse outcome or injury.Intuitive surgical, inc.(isi) contacted the site and obtained the following additional information regarding: the robotics coordinator was not present during the procedure but confirmed no patient injury per the case notes.

• Brand Name: ENDOWRIST
• Common Device Name: VESSEL SEALER
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale CA 94086
• MDR Report Key: 8101889
• Report Number: 2955842-2018-10692
• Device Sequence Number: 13717658
• Product Code: NAY
• UDI-Device Identifier: 10886874112745
• UDI-Public: (01)10886874112745(17)190531(10)M11170509
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K140189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 480322-07
• Device Lot Number: M11170509 0184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2018
• Initial Report FDA Received Date: 11/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES