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	09/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has not received the vessel sealer instrument involved with this complaint.Therefore, the root cause for the customer reported failure mode could not be determined.A follow up mdr will be submitted if additional information is received.A review of the system logs for this site, confirmed the instrument received was not the instrument used during this case.Failure analysis (fa) could not confirm the customer reported failure.The instrument was placed on an in-house system for functional testing.The self-test passed and delivered energy passed with no issue.The gap test passed with a 0.002¿ gauge.The electrical continuity test also passed.Based on the information provided, this event is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, it was alleged that the vessel sealer instrument did not seal completely.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 did not "seal completely".The customer used a vessel sealer instrument to complete the procedure.There was no repot of patent harm, adverse outcome or injury.Isi followed up with the initial reporter and obtained the following additional information: the robotic coordinator (roco) confirmed that during the sealing sequence, the customer heard an audible tone, however, did not note any error messages.No thermal effect or heat transfer was noted and the tissue was not thicker than normal.The roco confirmed there was no medical intervention required.The roco confirmed the procedure was completed as planned with no patient injury or harm.

• Brand Name: ENDOWRIST
• Common Device Name: VESSEL SEALER
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale CA 94086
• MDR Report Key: 8033875
• Report Number: 2955842-2018-10642
• Device Sequence Number: 16499121
• Product Code: NAY
• UDI-Device Identifier: 10886874112745
• UDI-Public: (01)10886874112745(17)200430(10)M10180503
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 09/11/2018

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: M10180503 0391
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2018
• Initial Report FDA Received Date: 11/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1