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

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	02/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2: age range < 18 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.
Event or Problem Description
It was reported via diego elite hcp retrospective chart review pmcf survey, the patient experienced a bleeding 1-24 hours of an adenoidectomy/tonsillectomy procedure while using a multidebrider power console.Additional surgical intervention was required.The patient was discharged fully recovered to baseline.

• Brand Name: MULTIDEBRIDER POWER CONSOLE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): GYRUS ACMI, INC.; 2925 appling rd; bartlett TN 38133
• Manufacturer (Section G): GYRUS ACMI, INC.; 2925 appling rd; bartlett TN 38133
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18297169
• Report Number: 1037007-2023-00029
• Device Sequence Number: 7250948
• Product Code: GEI
• UDI-Device Identifier: 00821925027770
• UDI-Public: 00821925027770
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Other,Foreign,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: Female