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

Model Number 410322-05

Device Problem Device Stops Intermittently (1599)

Patient Problems Failure to Anastomose (1028); Hemorrhage/Bleeding (1888)

Event Date 05/07/2015

Event Type  malfunction  

Event Description

It was reported that during a da vinci left hemicolectomy procedure, the sealing function of the endowrist one vessel sealer instrument seemed intermittent or would take an extremely long time for cut indicator to sound.On (b)(4) 2015, intuitive surgical, inc.(isi) obtained following information from isi clinical sales representative (csr): according to the csr, the vessel sealer instrument seemed to have issues from the beginning.The sealing function was intermittent or would take an extremely long time for the two beeps which typically occurs after sealing.The vessel sealer instrument did not appear to be sealing while the generator was beeping for a long time.There was no smoke and no bubbles coming out while it kept beeping.There were no error messages.The sealing cycle was sometimes in excess of 20+ seconds.According to the csr, the surgeon was dissecting omentum.There was little or no tissue effect sometimes.The surgeon utilized the cut function and there was bleeding, which was controlled quickly with either an additional seal or monopolar curved scissors.No blood transfusion was required.A new vessel sealer instrument was used to complete the procedure.There was no patient injury.

Manufacturer Narrative

Intuitive surgical, inc.(isi) has received the instrument involved with this complaint and completed investigations.Failure analysis investigation confirmed the customer reported complaint of intermittent sealing.The instrument was placed on an in-house system and passed self-check.The cut test passed and there was intermittent sealing.The gap gage test failed.This complaint is being reported due to the vessel sealer instrument sealing function being intermittent could likely cause or contribute to an adverse event, if the malfunction were to recur.

• Brand Name: ENDOWRIST ONE VESSEL SEALER
• 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: 4809463
• MDR Text Key: 16885151
• Report Number: 2955842-2015-00829
• 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: 05/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2015
• 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: M10150213 244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2015
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 05/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2015
• 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: 79 YR