MAUDE Adverse Event Report: GYRUS ACMI, INC. HOUSE-TYPE SS WIRE LP; REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL

Model Number	140187
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Unspecified Ear or Labyrinth Problem (4474)
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reports a patient contacted them and states that the mri completed at their facility while his house-type ss wire lp was implanted caused a dislodgement of the wire requiring a surgical procedure to replace it.The customer states the magnetic flux density of the mri machine used at their facility is 1.5 teslas.The customer further states that the radiology safety physician for the facility has reviewed this patients case and feels it is very unlikely that the mri could have dislodged the implanted wire (at this magnetic flux density level).
Additional Manufacturer Narrative
The device referenced in this report has not been returned to olympus for evaluation.The definitive cause of the customer's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device was not returned to the facility for evaluation.No visual inspection will occur for this device and the reported failure.A review of the device history record could not be performed because the lot number was not provided as the device was not returned in the original packaging.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The root cause has been determined to be that the patient was present around a mri greater than 3 tesla.Device pn:140187 is mri safe and functional until the device is exposed to more than 3 tesla.The customer stated that the facilities mri machine is 1.5 tesla, therefore the over exposure could not have happened at the reporting facility.A definitive root cause cannot be identified.

• Brand Name: HOUSE-TYPE SS WIRE LP
• Common Device Name: REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 9600 louisiana avenue north; brooklyn park, MN 55445 ; 5082077661
• MDR Report Key: 15019419
• Report Number: 3005975494-2022-00009
• Device Sequence Number: 20521432
• Product Code: ETA
• UDI-Device Identifier: 00821925015494
• UDI-Public: 00821925015494
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2022

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: 140187
• Device Lot Number: UNKNOWN
• 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: 06/15/2022
• Supplement Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 07/14/2022
• Supplement Report FDA Received Date: 08/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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; Required Intervention
• Patient Sex: Unknown