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

Catalog Number	004125
Health Effect - Clinical Codes	Tissue Damage (2104); Partial thickness (Second Degree) Burn (2694)
Date of Event	10/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Batch # unk.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested and the following was obtained: what is the surgeon¿s experience with the device? no, he has been using this device at this facility since 2013.Was the shaft rested against the patient¿s mouth and lip during use? yes, per one of the scrub technicians, the shaft rests against the side of mouth briefly.What action was taken to minimize heat transfer to the patient? the patient is lying on a cautery pad on the or bed as well as having a disposable pad placed in the abdomen.Is the customer alleging that the device may have caused or contributed to the patient burn? the physician suggested faulty insulation on the device.Does the surgeon believe that there was a malfunction of the device that lead to the patient burn? yes, faulty insulation.Was the device defective in any way? not that we could tell.If so, how?.
Event or Problem Description
It was reported that the doctor performed a tonsilectomy and adenoidectomy on a patient and, after the procedure was completed, noticed a second degree burn with blisters to the right corner of the patient's mouth, on both the lip and mouth.The patient was treated with bacitracin ointment and released.
Additional Manufacturer Narrative
(b)(4).Date sent: 11/20/2019.Investigation summary: one each 004125 lot 193819 was received for evaluation.The device was functionally tested and found to be performing within specifications.No abnormalities were observed during visual inspection.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 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: 9264015
• Report Number: 1721194-2019-00128
• Device Sequence Number: 1873690
• Product Code: GEI
• UDI-Device Identifier: 10614559105146
• UDI-Public: 10614559105146
• Combination Product (Y/N): N
• 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): 10/04/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 004125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Initial Date Received by Manufacturer: 10/04/2019
• Supplement Date Received by Manufacturer: 11/05/2019
• Initial Report FDA Received Date: 10/31/2019
• Supplement Report FDA Received Date: 11/20/2019
• Patient Sequence Number: 1