MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. VESSEL SEALER INSTRUMENT; ENDOSCOPIC ELECTROSURGICAL INSTRUMENT CONTROL SYSTEM

Model Number 410322

Device Problems Failure To Adhere Or Bond (1031); Loss of Power (1475); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/28/2015

Event Type  malfunction  

Event Description

It was reported during a da vinci surgical procedure, where an error message was shown on the erbe generator.The error appeared when the vessel sealer instrument spent a long time attempting to seal.Intuitive surgical followed up with the site and obtained the following information: the surgeon was experiencing longer seal time and was not aware that the vessel sealer instrument was not sealing since there were no error codes given off by the system.The surgeon did not hear the two audible high pitch tones, signaling that the generator had automatically stopped applying energy.There was no report of fragments falling into a patient.The planned surgical procedure was completed and no patient harm, adverse outcome, or injury was reported.

Manufacturer Narrative

The instrument has not been returned for evaluation.The root cause of the customer reported failure mode cannot be determined.If additional information is received, a follow-up mdr will be submitted.This complaint is being reported because of the allegation that the vessel sealer instrument was experiencing longer sealing time then normal and no error codes were shown on the system.

• Brand Name: VESSEL SEALER INSTRUMENT
• Type of Device: ENDOSCOPIC ELECTROSURGICAL INSTRUMENT CONTROL SYSTEM
• Manufacturer (Section D): INTUITIVE SURGICAL,INC.; sunnyvale CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC.,; 950 kifer rd; sunnyvale CA 9408 6
• Manufacturer Contact: tabitha reed ; 950 kifer rd; sunnyvale, CA 94086
• MDR Report Key: 4795451
• MDR Text Key: 5855938
• Report Number: 2955842-2015-00793
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K110639
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 410322
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 04/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1