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

Model Number	050-070
Medical Device Problem Code	Device Remains Activated (1525)
Health Effect - Clinical Codes	Burn, Thermal (2530); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Suspect device has been returned to a&e medical and was observed to be contaminated with residue appearing to be blood.Device has been sent out for decontamination.User-facility indicated the device had patient contact, however, there was no patient harm.A follow-up report concluding the investigation will be issued once the device returns from sterilizer.
Event or Problem Description
Fda medwatch 3500a report ((b)(4)) was received on 6/3/2019 on behalf of a user-facility indicating the device failed to deactivate once the activator was pressed and had to be unplugged to deactivate it.User-facility indicated the device had patient contact, however, there was no patient harm.
Event or Problem Description
Mdr (b)(4) was received on 6/3/2019 on behalf of a user-facility indicating the device failed to deactivate once the activator button was pressed and had to be unplugged to deactivate it.Suspect device was returned to a&e medical and was observed to be contaminated with residue appearing to be blood.The device was sent out for decontamination.User-facility indicated the device had patient contact, however, there was no patient harm.An initial a&e medical mdr 2242056-2019-00005 was submitted on 7/1/2019.Mdr 2242056-2019-00005-001 concludes the investigation after the device was evaluated.
Additional Manufacturer Narrative
An mdr (b)(4) was received on 6/3/2019 on behalf of a user-facility indicating the device failed to deactivate once the activator button was pressed and had to be unplugged to deactivate it.User-facility indicated the device had patient contact, however, there was no patient harm.The returned unit was received intact with the cannula slightly bent, which was most-likely done by the surgeon/user prior to use as it is standard practice with this device per the ifu.The returned unit was electrically tested in accordance with standard procedures.Based on the test results of the returned device, it can be concluded that the unit meets all electrical test requirements.The complaint could not be replicated.The returned unit was observed to have a wire welded on the cannula in a position under the activator tongue of the finger-tip control.There was a gap present between the cannula and the tongue component thus there was no electrical connection.While we were unable to replicate the failure reported, it is possible that if a high voltage was introduced during use, a spark could have been generated between the welded wire and the tongue activating the device.No complaint trend exists for such an occurrence and it remains purely speculative to assume the weld position caused failure, however, as a matter of continuous improvement operating procedures were revised to indicate the weld re-position on the cannula.By repositioning the weld to a different location on the cannula, it allows increased separation between the cannula and activator tongue ensuring tongue clearance.An initial a&e medical mdr 2242056-2019-00005 was submitted on 7/1/2019.Mdr 2242056-2019-00005-001 concludes the investigation.

• Brand Name: SUCTION COAGULATOR
• Common Device Name: SUCTION COAGULATOR
• Manufacturer (Section D): A&E MEDICAL CORPORATION; 5206 asbury road; farmingdale, nj NJ 07727
• MDR Report Key: 8750812
• Report Number: 2242056-2019-00005
• Device Sequence Number: 13962865
• Product Code: GEI
• UDI-Device Identifier: 20841291105036
• UDI-Public: 20841291105036
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2020

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: 12/01/2022
• Device Model Number: 050-070
• Device Catalogue Number: 050-070
• Device Lot Number: 208C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2019
• Initial Date Received by Manufacturer: 06/03/2019
• Supplement Date Received by Manufacturer: 06/03/2019
• Initial Report FDA Received Date: 07/01/2019
• Supplement Report FDA Received Date: 02/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR