MAUDE Adverse Event Report: GYRUS ACMI, INC MULTIDEBRIDER POWER CONSOLE; OLYMPUS ENERGY POWER SYSTEM (EPS)

Model Number MDCONS100

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The subject device has not yet been received for evaluation.The cause of the issue cannot be determined at this time.If additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that during preparation for use, the device exhibited error 12 error message.According to the reporter, the intended procedure was completed by switching to another similar device.Type of procedure, serial number of the device used to complete the procedure was not provided.There was no patient harm or impact reported due to the event.

• Brand Name: MULTIDEBRIDER POWER CONSOLE
• Type of Device: OLYMPUS ENERGY POWER SYSTEM (EPS)
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: kenneth pittman ; 2925 appling rd; bartlett, TN 38133 ; 9013785969
• MDR Report Key: 10397478
• MDR Text Key: 228231305
• Report Number: 1037007-2020-00033
• Device Sequence Number: 1
• Product Code: GIE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123429
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/12/2020

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
• Device Operator: Health Professional
• Device Model Number: MDCONS100
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/13/2020
• Initial Date FDA Received: 08/12/2020
• 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