MAUDE Adverse Event Report: GYRUS ACMI, INC. MULTIDEBRIDER POWER CONSOLE; ELECTROSURGICAL, CUTTING

Model Number	MDCONS100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The user reported via diego elite hcp retrospective chart review pmcf survey, when using a multidebrider power console during soft shaving of the head and neck, a patient experienced periprocedural bleeding.The extent of the bleeding is unknown, however; additional surgical intervention was required to manage the bleeding.The patient fully recovered to baseline at time of hospital discharge.
Additional Manufacturer Narrative
A2: age range 35-55 years.The device was not returned for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

• Brand Name: MULTIDEBRIDER POWER CONSOLE
• Common Device Name: ELECTROSURGICAL, CUTTING
• Manufacturer (Section D): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer (Section G): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18291193
• Report Number: 3003790304-2023-00445
• Device Sequence Number: 12429128
• Product Code: GEI
• UDI-Device Identifier: 00821925027770
• UDI-Public: 00821925027770
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K123429
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/08/2023

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 Model Number: MDCONS100
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 12/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male