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

Model Number 410322-04

Device Problems Failure To Adhere Or Bond (1031); Loss of Power (1475); Failure to Cut (2587); Device Operates Differently Than Expected (2913)

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

Event Date 11/21/2014

Event Type  malfunction  

Event Description

It was reported that during a da vinci left lower lung mass removal procedure, the endowrist one vessel sealer instrument did not work properly.Both cautery and cut did not work.A new device was opened and worked correctly.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.On (b)(4) 2014, intuitive surgical inc.(isi) contacted initial reporter who clarified the instrument was working then stopped working.She indicated the instrument would not seal or cut.There were unspecified indications the instrument just didn't work so the surgeon replaced the instrument with a new one.She was unaware if any error messages occurred.No patient harm was reported and the procedure was completed without further issue.

Manufacturer Narrative

The instrument was returned and evaluated.Failure analysis investigation found the electrode at the grip assembly was found broken.It was jutting out of the grip.The instrument was placed on system and passed a self-test.A cut test was performed and inconsistent cuts were observed intermittently.Cautery function failed as no steam/smoke emitted when seal pedal was pressed with a wet paper towel held between the grips.One electrode at the grip assembly was found dislodged from the molded grip preventing sealing/cautery function of the instrument because both electrodes now touch and could likely cause shorting when energy is initiated.This defect also affected cutting function because the knife blade was no longer restricted by the slot allowing additional movement when the knife was engaged, affecting the cut precision.No defects were found on the surface of both grips.The dislodged electrode radius was within specifications.Isi has conducted a device history record (dhr) review for this device and did not find any non-conformances that were related to this reported event.The customer reported complaint does not itself constitute a mdr reportable event; however; the failed cautery test, 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: 4344248
• MDR Text Key: 5201278
• Report Number: 2955842-2014-05889
• 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: 11/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2014
• 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: S10130309 886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2014
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 11/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2013
• 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
• Patient Age: 44 YR
• Patient Weight: 98