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

Catalog Number	004010J
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary as the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.
Event or Problem Description
It was reported that during a tonsillectomy and adenoidectomy procedure, the protective coating on product did not protect patient tongue.The patient tongue was burned.The procedure was and was 15 mins in length.The patient was in the supine position.No prep solution or antiseptics/cleansers were used.The generator settings were cut 35 and coag 35.This was used with covidien valleylab ft10.There was no functional issues noted with the device during the case.The settings were not increased.The patient call the next day.The surgeon discovered a 5 mm 2nd degree burn on the left side of the mouth.The skin lesion report states the patient's skin condition at the lesion site before the procedure was blistered and crusted.
Additional Manufacturer Narrative
(b)(4).Additional information obtained: how was the burn treated? - the burn was treated with polysporin to the skin at the corner of the mouth.
Additional Manufacturer Narrative
(b)(4).Date sent: 12/16/2019.Investigation summary: 14 each 004010j lot 190190.The device involved in event was not returned for evaluation.The 14 returned were new unopened devices.Each of the devices were visual inspected and no abnormalities were observed.Each of the devices were functionally tested and found to be performing within specifications.The complaint is unconfirmed.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.

• Brand Name: SUCTION COAGULATOR FTSW 10FR
• Common Device Name: SUCTION COAGULATOR FOOTSWITCHING 10 FR
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 8668888
• Report Number: 1721194-2019-00095
• Device Sequence Number: 10823783
• Product Code: GEI
• UDI-Device Identifier: 10614559105122
• UDI-Public: 10614559105122
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K072559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/21/2019

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: 01/31/2024
• Device Catalogue Number: 004010J
• Device Lot Number: 190190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Initial Date Received by Manufacturer: 05/21/2019
• Supplement Date Received by Manufacturer: 06/07/2019; 11/26/2019
• Initial Report FDA Received Date: 06/04/2019
• Supplement Report FDA Received Date: 06/07/2019; 12/16/2019
• Patient Sequence Number: 1
• Patient Age: 8 YR
• Patient Weight: 40