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	10/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 was not sealing properly.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 sigmoid colectomy procedure, the vessel sealer instrument was not working.The customer was able to complete the procedure with no report of patient harm, adverse outcome or injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: an error message was displayed stating that the instrument was not working properly and to remove and reinstall the instrument.The error message was not a persistent message.Although, the instrument was removed and reinstalled, it would sometimes continue to function properly.It properly sealed numerous times throughout the case and still worked a few times after the error message had occurred.
Additional Manufacturer Narrative
Failure analysis confirmed through error logs the customer reported complaint.The error log review indicated ¿error 22024¿ occurred during the procedure three times.This error is defined as ¿when the instrument is commanded to strong grip torque (usually for vessel seal function), the grip torque is outside the expected range (most likely too low).¿ as a result, this would prompt the user with a error screen message of "sealing malfunction, remove and reinstall, if issue persists, discard instrument.".

• Brand Name: ENDOWRIST
• Common Device Name: VESSEL SEALER
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale CA 94086
• MDR Report Key: 8072072
• Report Number: 2955842-2018-10672
• Device Sequence Number: 1593948
• Product Code: NAY
• UDI-Device Identifier: 10886874112745
• UDI-Public: (01)10886874112745(17)200630(10)M10180615
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2018

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
• Operator of Device: Health Professional
• Device Model Number: 480322-07
• Device Lot Number: M10180615 0354
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/24/2018
• Supplement Date Received by Manufacturer: 12/03/2018
• Initial Report FDA Received Date: 11/14/2018
• Supplement Report FDA Received Date: 12/21/2018
• 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