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	09/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint is being reported due to the following conclusion: while there was no report of any patient harm, adverse outcome or injury, recurrence of the reported sealing issue with the vessel sealer instrument could cause or contribute to an adverse event.Furthermore, it is unknown what caused the sealing issue.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the vessel sealer instrument did not "seal effectively".Prior to the issue being observed, the instrument had successfully completed a seal function.The customer stated that thermal effect on the tissue was observed; however, no audible tones or error messages were noted.No obstructions or interferences between the instrument jaws was noted.A back-up vessel sealer instrument was used to complete the procedure.There was no report of fragments falling inside the patient, patient harm, adverse outcome or injury.

• Brand Name: ENDOWRIST
• Common Device Name: VESSEL SEALER
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale CA 94086
• MDR Report Key: 7915673
• Report Number: 2955842-2018-10555
• Device Sequence Number: 856788
• Product Code: NAY
• UDI-Device Identifier: 10886874112745
• UDI-Public: (01)10886874112745(17)200630(10)M10180615
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 09/05/2018

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 09/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1