MAUDE Adverse Event Report: TENEX HEALTH TX1 TISSUE REMOVAL SYSTEM - MICROTIP; ULTRASONIC SURGICAL ASPIRATOR

Catalog Number 554-1003-001

Device Problem Loss of Power (1475)

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

Event Date 06/01/2015

Event Type  Injury  

Event Description

Per the facility contact, immediately prior to surgical start time, it was identified that the pressure cuff was no longer with the console.The sales rep was called and notified of the problem.He presented an alternate solution involving use of a standard iv fluid pressure bag to replace the absent cuff.The operating surgeon was notified about this solution and chose to proceed with the surgery.With the sales rep on speaker phone the surgical team followed his instructions for priming and then using the device.While attempting to use the device in the surgical incision, the hand piece shut down after only 2 seconds of cutting (timer stopped 2 sec).After several minutes of troubleshooting with the sales rep, a second hand piece was opened and connected only to fail with the same result as the first.The surgeon then chose to use an open approach to the surgery.After the surgery one of the hand pieces was retained for return to the manufacturer, the other was inadvertently disposed of.

Manufacturer Narrative

The device is being returned for evaluation.Once the evaluation is complete a supplemental mdr will be filed.One mdr is being filed for this event.The center tried to use two microtips on the same patient with both microtips ending in a stopped cutting event.The two microtips are from the same lot number.After the failure of the second microtip, the doctor opted to convert to an open procedure.It is the conversion to an open procedure that makes this a reportable event.Per the facility contact, there was no injury or complication to the patient caused by the reported failure.

• Brand Name: TX1 TISSUE REMOVAL SYSTEM - MICROTIP
• Type of Device: ULTRASONIC SURGICAL ASPIRATOR
• Manufacturer (Section D): TENEX HEALTH; lake forest CA
• Manufacturer Contact: 26902 vista terrace; lake forest, CA 92630 ; 9492388124
• MDR Report Key: 4877662
• MDR Text Key: 6064485
• Report Number: 3009750704-2015-00589
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123640
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2015
• Device Catalogue Number: 554-1003-001
• Device Lot Number: 01615-05
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/01/2015
• Initial Date FDA Received: 06/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 46 YR