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	09/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event was not confirmed through failure analysis investigation.The instrument was tested with an in-house system and passed both the engagement and self tests.Testing found the instrument exhibiting intuitive motion in all directions with the grips properly opening and closing.The cut and energy delivery functionality including the knife slot, gap test and grip force were verified and passed specification.The instrument operated as expected.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 user observed that energy was unable to be activated on the vessel sealer instrument.The user completed the procedure using the backup instrument with no further issue reported.No fragment fell inside the patient.No known impact or patient consequence was reported.

• Brand Name: ENDOWRIST
• Common Device Name: VESSEL SEALER
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 9137674
• Report Number: 2955842-2019-10759
• Device Sequence Number: 2694271
• Product Code: NAY
• UDI-Device Identifier: 10886874112745
• UDI-Public: (01)10886874112745(17)200630(10)L10180613
• Combination Product (Y/N): N
• PMA/510(K) Number: K140189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/04/2019

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: L10180613 0083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 09/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1