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

Model Number 410322-05

Device Problems Device Stops Intermittently (1599); Device Inoperable (1663)

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

Event Date 10/01/2014

Event Type  malfunction  

Event Description

It was reported during a da vinci surgical procedure that the endowrist one vessel sealer instrument's cautery function would not energize.On 10/16/2014, intuitive surgical inc.(isi) contacted the initial reporter of this complaint.It was stated that sealing issues were observed with the vessel sealer instrument, approximately half way through the procedure.The vessel sealer instrument's cauterizing function worked as expected, then it's function became intermittent throughout the procedure.The planned surgical procedure was completed.There was no report of fragments falling into the patient.There was no patient harm, adverse outcome or injury reported.

Manufacturer Narrative

The instrument was returned and evaluated.Failure analysis investigation was unable to replicate the customer reported complaint.The instrument passed electrical continuity testing.Visual inspection showed no blade exposed or damage to the grip assembly.Light biodebris resided within the garage track.A cautery and seal function test was performed with no issue.No loss of power and no intermittent energy were observed.The beep noise indicator went on when sealing function was completed.Grip force testing was performed on the grips as additional testing.Remotefe data did not confirm any cautery/sealing problem.No other damage was found.The customer reported complaint does not in itself constitute a mdr reportable event; however; the instrument failing to seal if to recur could cause or contribute to an adverse event.

• 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: 4196034
• MDR Text Key: 20294161
• Report Number: 2955842-2014-05531
• 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: 10/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 410322-05
• Device Lot Number: M10140826 626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2014
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 10/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2014
• 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
• Patient Age: 46 YR
• Patient Weight: 98