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

Model Number 410322-04

Device Problem Device Stops Intermittently (1599)

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

Event Date 06/12/2014

Event Type  malfunction  

Event Description

It was reported that during a da vinci surgical procedure, the power was going on and off while we were cauterizing.There were no reports of fragments falling into a patient.The planned surgical procedure was completed and no patient harm, adverse outcome or injury was reported.Intuitive surgical inc.(isi) contacted the initial reporter and obtained additional information regarding the reported event.She stated the surgeon did not experience any incomplete seals but rather they felt the instrument lost power.No error messages were reported and they had normal audible tones during use.They verified the connections were seated properly but rather than troubleshooting further they immediately replaced the instrument with a new vessel sealer and completed the planned procedure.She stated there was no harm to the patient.

Manufacturer Narrative

The instrument was returned and evaluated.Failure analysis was unable to confirm the reported complaint.Electrical continuity testing was performed and passed.Visual inspection showed no blade exposed or damage to the grip assembly.Heavy biodebris resided within the garage track.A cautery and seal function test was performed with no issue.A wet paper towel was held between the grips and began to smoke when the seal pedal was pressed.No loss of power and no intermittent energy were observed.An audible indicator was heard when the seal function was complete.A grip force test were within specifications.All other specifications were within limits.No issues were found in log files.An additional observation not reported was a dislodged snake wrist.No pieces are missing.No other damage was found.The customer reported complaint does not itself constitute a mdr reportable event; however; the dislodged wrist, found during failure analysis evaluation could likely cause or contribute to an adverse event if the failure mode were to recur.

• Brand Name: ENDOWRIST ONE VESSEL SEALER INSTRUMENT
• Type of Device: ENDOSCOPIC ELECTROSURGICAL INSTRUMENT
• 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: 3997292
• MDR Text Key: 4781092
• Report Number: 2955842-2014-04859
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 410322-04
• Device Lot Number: M10131209 058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2014
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 07/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1