MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. SUCTION COAGULATOR HDSW 12FR; SUCTION COAGULATOR HANDSWITCHING 12 FR

Catalog Number	4325
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 7/12/2019.Batch # unk.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 an unknown procedure, when the pedal was released on the suction coagulator, the device was still suctioning and the device was sticking to tissue.When the doctor pushes the button to activate, the device doesn't immediately start activating.When the device does start activating and the doctor released the activation button, the device continues to activate.The doctor would continue to use the same device but would be mindful of the activation issue.There were no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 8/2/2019.Investigation summary: 1 each sample of 004325 lot 184711 was returned for evaluation.The sample received is not the device that was reported in the event.The sample returned of the same lot was functionally tested and found to be performing within specifications.As the device that is reported in the complaint was not returned, an analysis investigation could not be performed.All testing performed on the sample of the same lot found the device within specifications.A conclusion could not be reached as to what may have caused or contributed to the event.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 12FR
• Common Device Name: SUCTION COAGULATOR HANDSWITCHING 12 FR
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 8786533
• Report Number: 1721194-2019-00104
• Device Sequence Number: 19358555
• Product Code: GEI
• UDI-Device Identifier: 10614559105160
• UDI-Public: 10614559105160
• 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: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2019

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 Catalogue Number: 4325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Initial Date Received by Manufacturer: 06/21/2019
• Supplement Date Received by Manufacturer: 07/16/2019
• Initial Report FDA Received Date: 07/12/2019
• Supplement Report FDA Received Date: 08/02/2019
• Patient Sequence Number: 1