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	06/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.Visual inspection found no damage to the instrument.Failure analysis investigation was not able to replicate the reported complaint.The instrument was placed and driven on an in-house system.The instrument was fully functional and passed the cautery test with no issues.A device history record (dhr) review for this device was conducted and did not find any non-conformances that would affect any material of the final product and/or the quality or performance of the instrument.This complaint 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.While there was no report of any patient harm, adverse outcome or injury, recurrence of the reported sealing issue could cause or contribute to an adverse event.
Event or Problem Description
It was reported that during a da vinci-assisted right hemicolectomy procedure, the endowrist vessel sealer instrument suddenly stopped working.The customer reported that the instrument worked fine at the beginning of the procedure and then suddenly stopped sealing.The customer was unable to specify if the system displayed an error message.Following this, a backup vessel sealer instrument was inserted and used.The planned surgical procedure was completed with no further issues reported.There was no report of fragments falling inside the patient, patient harm, adverse outcome or injury.Intuitive surgical, inc.(isi) made multiple follow up attempts to reach the customer to obtain additional information; however, no further information had been obtain as of date of this report.

• Brand Name: ENDOWRIST
• Common Device Name: VESSEL SEALER
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• MDR Report Key: 7670201
• Report Number: 2955842-2018-10342
• Device Sequence Number: 2771344
• Product Code: NAY
• UDI-Device Identifier: 10886874112745
• UDI-Public: (01)10886874112745(17)200331(10)M11180313
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/14/2018

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: M11180313 0333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2018
• Initial Report FDA Received Date: 07/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1