MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; VESSEL SEALER

Model Number	480322-07
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Isi has not received the vessel sealer instrument involved with this complaint.Therefore, the root cause of the alleged customer failure cannot be determined.A follow-up mdr will be submitted if the instrument is returned (post failure analysis evaluation) or if additional information is received.The system is programmed to display a warning message stating, "blade may be exposed" and a warning tone.The impact to patient presented by this event is low, as the surgeon is able to quickly detect the failure.The surgeon has visibility of this failure in multiple ways: 1.If a dislodged blade occurs, an error message is shown on the surgeon console and the patient side cart monitors, indicating an exposed blade.2.If the blade has dislodged and is unable to retract back into the instrument grips, the system will no longer allow the user to attempt to extend the blade.The instrument and accessory user manual states: "always have a backup instrument available to complete the surgical procedure in case of instrument failure." this complaint is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, it was alleged that the patient sustained an "injury".No other information was been obtained.At this time, the root cause of the reported "injury" is unknown.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the surgical staff encountered an exposed blade issue with the vessel sealer instrument after a system reboot.It was initially reported that there was patient injury and no instrument fragments fell inside the patient.Intuitive surgical, inc.(isi) has made multiple attempts to contact the site to obtain additional information regarding the reported event.However, as of the date of this report, no additional information has been obtained.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received additional information that there was no adverse event reported.The customer had made an error while calling in this reported event.The reporter confirmed that there was no patient injury, hence this will be deemed as a non-reportable complaint.Based on the additional information received, this mdr report is being retracted.

• Brand Name: ENDOWRIST
• Common Device Name: VESSEL SEALER
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer road; sunnyvale CA 94086
• MDR Report Key: 7705462
• Report Number: 2955842-2018-10391
• Device Sequence Number: 756984
• Product Code: NAY
• UDI-Device Identifier: 10886874112745
• UDI-Public: (01)10886874112745(17)200229(10)M10180215
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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,Followup
• Report Date (Section B): 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 480322-07
• Device Lot Number: M10180215
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/25/2018
• Supplement Date Received by Manufacturer: 07/25/2018
• Initial Report FDA Received Date: 07/19/2018
• Supplement Report FDA Received Date: 08/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES; DA VINCI INSTRUMENTS AND ACCESSORIES
• Outcome Attributed to Adverse Event: Other