MAUDE Adverse Event Report: STERILMED, INC.; SCALPEL, ULTRASONIC, REPROCESSED

Model Number ETHACE45E

Device Problem Continuous Firing (1123)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2015

Event Type  malfunction  

Event Description

It was reported that during an adrenalectomy the device activated all by itself.Another device was used to complete the procedure.There was no patient injury.Additional information was requested, but no additional information was provided.A supplemental report will be sent if additional information is received.

Manufacturer Narrative

The device was received by the manufacturer.A supplemental report will be sent when the device investigation is completed.

Manufacturer Narrative

The device returned to the manufacturer was an ethace36e.The device was returned in good visual condition.Upon evaluation, the clamp arm and trigger operated as intended.The blade did not appear fractured.The device was connected to both ethicon harmonic scalpel generator 300 gen 04 and gen 11 generators and was triggered multiple times.No activation was detected from the device without manual engagement and triggering from the hand control buttons.The device passed all electrical testing including the self-test and button tests.The device history record was reviewed, and no discrepancies were noted.As the device passed all visual inspection and functional testing criteria, no conclusion could be made as to what may have caused the reported event.

• Type of Device: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STERILMED, INC.; 11400 73rd ave n; maple grove MN
• Manufacturer Contact: patricia kaufman ; 5010 cheshire parkway, suite 2; plymouth, MN 55446 ; 7634888321
• MDR Report Key: 4651448
• MDR Text Key: 5759109
• Report Number: 2134070-2015-00015
• Device Sequence Number: 1
• Product Code: NLQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050343
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2015
• Device Model Number: ETHACE45E
• Device Catalogue Number: ETHACE45E
• Device Lot Number: 1809555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2015
• Initial Date FDA Received: 04/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2014
• 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