MAUDE Adverse Event Report: A&E MEDICAL CORPORATION A&E MEDICAL CORPORATION - SUCTION COAGULATOR

Model Number	050-005
Medical Device Problem Codes	Device Issue (2379); Device Operational Issue (2914)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	05/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complained upon suction coagulator device (050-005, lot 198c) was returned to a&e medical for investigation.The device was received on 7/24/2017.(ref.(b)(4)) the device was reviewed through the clear plastic packaging upon receipt and found to be satisfactory visually without opening the package.The device has been sent to the sterilizer as part of the a&e medical decontamination process on 8/3/2017.The device has not returned as of this preliminary report.The device will be reviewed and electrically tested upon its return, estimated to be the week of 8/14/2017.A follow up report shall be submitted upon completion of the investigation.
Event or Problem Description
Patient was found to have lower lip swelling, thought to be due to electrical burn from suction coagulator.Patient was treated with polysporin and observed closely.
Additional Manufacturer Narrative
The complained upon suction coagulator device (050-005, lot 198c) was returned to a&e medical for investigation.The device was received on 7/24/2017.(ref.Rga 170717-02) the device was reviewed through the clear plastic packaging upon receipt and found to be satisfactory visually without opening the package.The device has been sent to the sterilizer as part of the a&e medical decontamination process on 8/3/2017.The device has not returned as of this preliminary report.The device will be reviewed and electrically tested upon its return, estimated to be the week of 8/14/2017.A follow up report shall be submitted upon completion of the investigation.Upon review of returned device after decontamination process it was observed the returned device was in a sealed pouch that was never opened.A call to the complainant confirmed the returned device was not the device complained upon.The complained upon device was discarded by the user.The returned device was from the same lot number and thus a&e medical investigated and tested the returned device.(b)(4).
Event or Problem Description
Patient was found to have lower lip swelling, thought to be due to electrical burn from suction coagulator.Patient was treated with polysporin and observed closely.

• Brand Name: A&E MEDICAL CORPORATION - SUCTION COAGULATOR
• Common Device Name: SUCTION COAGULATOR
• Manufacturer (Section D): A&E MEDICAL CORPORATION; 5206 asbury road; farmingdale NJ 07727
• MDR Report Key: 6786367
• Report Number: 2242056-2017-00004
• Device Sequence Number: 16159441
• Product Code: FEH
• UDI-Device Identifier: 10841291104865
• UDI-Public: 10841291104865
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K881413
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2017

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: Physician
• Device Expiration Date: 12/01/2021
• Device Model Number: 050-005
• Device Catalogue Number: 050-005
• Device Lot Number: 198C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2017
• Supplement Date Received by Manufacturer: 07/13/2017
• Initial Report FDA Received Date: 08/10/2017
• Supplement Report FDA Received Date: 09/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention