MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. SUCTION COAGULATOR HDSW 10FR; SUCTION COAGULATOR HANDSWITCHING 10 FR

Catalog Number	004125
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.The lot history records were reviewed and the manufacturing criteria were met prior to the release of this lot.
Event or Problem Description
It was reported that during a tonsils adenoids, the surgeon was using a suction colagator and they were on a foot pedal, he was removing the device from the patient and ending up burning the patient on the lip.Small electrocautery burn (4x4mm) on the right superior lip border near oral commissure.When the surgeon released his foot from the petal, the energy did not stop to the device.
Additional Manufacturer Narrative
(b)(4).Date sent: 12/20/2018.Investigation summary: the device functioned properly during testing with megapower generator and megadyne footswitch.A dhr review was performed, and there is no evidence of device defect or malfunctions.No self activation (continuous activation) was observed during testing.Although we have unable to determine the exact cause of the event, we have verified the proper performance of the device.

• Brand Name: SUCTION COAGULATOR HDSW 10FR
• Common Device Name: SUCTION COAGULATOR HANDSWITCHING 10 FR
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 8118201
• Report Number: 1721194-2018-00054
• Device Sequence Number: 19227262
• Product Code: GEI
• UDI-Device Identifier: 10614559105146
• UDI-Public: 10614559105146
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K072559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 004125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2018
• Initial Date Received by Manufacturer: 11/08/2018
• Supplement Date Received by Manufacturer: 11/08/2018
• Initial Report FDA Received Date: 11/29/2018
• Supplement Report FDA Received Date: 12/20/2018
• Patient Sequence Number: 1