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

Model Number 140187

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Unspecified Ear or Labyrinth Problem (4474)

Event Type  Injury  

Event 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).

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.

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
• Type of Device: 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
• MDR Text Key: 295953110
• Report Number: 3005975494-2022-00009
• Device Sequence Number: 1
• Product Code: ETA
• UDI-Device Identifier: 00821925015494
• UDI-Public: 00821925015494
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K760433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention