MAUDE Adverse Event Report: GYRUS ACMI, INC. MCGEE PL/SS PSTN .6DX5.00; REPLACEMENT, OSSICULAR PROSTHESIS

Model Number	140335
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
In communication with the customer, the technical assistance center (tac) support engineer advised that this would be an "off-labeled " use.Tac provided customer a copy of instruction for use (ifu) for this device.In addition, follow up has been made and still in progress to gather additional information regarding the event reported.To date, no response is received.Supplemental report(s) will be submitted should any relevant new information is available and or received.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Event or Problem Description
Customer called to report that the doctor implanted an expired item in the patient.Customer wanted to know if there are any negative effects on the patient.No harm was reported, no patient injury reported to date.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the device was not used in accordance with the provided labeling, and thus, it is considered as off-label use.Olympus will continue to monitor field performance for this device.

• Brand Name: MCGEE PL/SS PSTN .6DX5.00
• Common Device Name: REPLACEMENT, OSSICULAR PROSTHESIS
• 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: 16641587
• Report Number: 1037007-2023-00015
• Device Sequence Number: 6156470
• Product Code: ETA
• UDI-Device Identifier: 00821925015258
• UDI-Public: 00821925015258
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K760433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2023

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 Model Number: 140335
• Device Lot Number: MH514801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2023
• Supplement Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/29/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown