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

Model Number MDCONS100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Tissue Injury (4559)

Event Date 05/01/2023

Event Type  Injury  

Manufacturer Narrative

A2: the exact age of the patient is unknown, but it is known the patient was 18 to 34 years of age.B3: the event date was in may 2023, however the exact day is unknown.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 Description

It was reported via a post market clinical follow-up (pmcf) survey, the diego elite was used for soft tissue shaving of the head and neck.The device adequately coagulated bone and soft tissue during the procedure.The following adverse events occurred: bleeding: occurred 1 to 24 hours after the procedure and required re-hospitalization.The patient made a partial recovery to baseline.There were patient comorbidities at the time of procedure that may have attributed to the bleeding.Mucosal injury: occurred less than 1 hour after the procedure and required additional medication.The patient made a partial recovery to baseline.There were patient comorbidities at the time of procedure that may have attributed to the mucosal injury.Nasal symptoms: occurred less than 1 hour after the procedure and required re-hospitalization.The patient made a partial recovery to baseline.There were patient comorbidities at the time of procedure that may have attributed to the nasal symptoms.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial/lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, due limited information provided by the survey, the root cause of the event could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: MULTIDEBRIDER POWER CONSOLE
• Type of Device: 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: 18263981
• MDR Text Key: 329665938
• Report Number: 1037007-2023-00024
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00821925027770
• UDI-Public: 00821925027770
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123429
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MDCONS100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Male