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	04/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the vessel sealer involved with this complaint and completed the device evaluation.Failure analysis did not confirm the customer reported complaint.The instrument was placed and driven on an in-house system.The instrument passed the self-test.The instrument moved intuitively with full range of motion in all directions.The grips opened and closed properly, energy delivery test was performed and passed.The gage pin test passed at straight 6.82 lbs yaw at 6.59 lbs and pitch at 7.00 lbs.Gage pin test passed at.002 mm.Review of the logs do not exhibit any sealing errors.The instrument was found to have a the blade exposed in between the grips at.098".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 was insufficiently sealing.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 surgical procedure, the vessel sealer instrument would not activate energy.There was no report of patient harm, adverse outcome or injury.Intuitive surgical, inc.(isi) followed up with the customer and was able to obtain the following additional information: the instrument was working at the start of procedure but stopped sealing approximately 30 minutes into the procedure.The customer did not take note of the error message but audible tones were heard during the sealing cycle.

• Brand Name: ENDOWRIST
• Common Device Name: VESSEL SEALER
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• MDR Report Key: 7694597
• Report Number: 2955842-2018-10385
• Device Sequence Number: 19164850
• Product Code: NAY
• UDI-Device Identifier: 10886874112745
• UDI-Public: (01)10886874112745(17)190731(10)M10170801
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K140189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/27/2018

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: M10170801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2018
• Initial Report FDA Received Date: 07/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1