MAUDE Adverse Event Report: GYRUS ACMI, INC. MASS EYE AND EAR PISTON 4.25MM X .6MM; PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT

Model Number	70140801
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.
Event or Problem Description
Olympus received an email from the customer reporting that she has experienced an difficult recovery and major post-operative complications after an ent procedure in 2017.Additional details have been requested from the customer regarding the reported event.At this time, no additional information has been provided.
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.It has been over 6 years since the subject device was manufactured.Based on the results of the investigation, it was determined that there is no manufacturing, material or processing related cause for this reported issue.Since no additional information regarding the event was obtained, the root cause could not be determined.This supplemental report includes information added to h4.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This report is being submitted to correct the legal manufacturer¿s contact information and facility registration number.The facility registration number is 1037007.

• Brand Name: MASS EYE AND EAR PISTON 4.25MM X .6MM
• Common Device Name: PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT
• 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: 16154185
• Report Number: 2951238-2023-00293
• Device Sequence Number: 6958695
• Product Code: ETB
• UDI-Device Identifier: 00821925020474
• UDI-Public: 00821925020474
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K760435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/19/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 70140801
• Device Lot Number: MH636283
• 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: 12/22/2022
• Supplement Date Received by Manufacturer: 03/04/2023; 06/19/2024
• Initial Report FDA Received Date: 01/12/2023
• Supplement Report FDA Received Date: 03/22/2023; 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/05/2016
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female