MAUDE Adverse Event Report: GYRUS ACMI, INC SMART STAPES IMPLANT; SMART 360 PISTON

Model Number UNKNOWN

Device Problem Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

The patient reported to olympus technical assistance center (tac), when the head is placed in back of the magnetic resonance imaging (mri) magnet, it feels like the smart stapes piston is moving in the back of the ear.The patient received the smart stapes implant about four weeks ago and the patient is an mri technician.There were no reports of patient harm associated with this event.

Manufacturer Narrative

In speaking with olympus technical assistance center (tac), the patient reported feeling the smart stapes implant move whenever the patient's head is near the mri magnet.Tac instructed the patient to contact their doctor.According to the patient, a follow up appointment has already been scheduled.The investigation is ongoing and follow up with the reporter is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the reporter.

Event Description

Additional information was obtained from the patient regarding this event.The patient described the sensation experienced as a pushing on the implant, which occurred when crossing the flux lines in the mri.Follow up with surgeon determined that there had been no decrease in the patient¿s hearing which would have been indicative of the implant becoming bent or displaced.As the patient¿s hearing had not decreased, the surgeon did not physically evaluate the implant for any displacement.The patient was transferred out of the mri department and is no longer experiencing the feeling of pushing on the implant.

Manufacturer Narrative

Correction: h10 (redaction).This supplemental report is to inform that upon further review, this is not a reportable malfunction.Per the legal manufacturer, there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.Additionally, the patient indicated no harm occurred.As the device is still implanted in the patient, the device will not be returned for physical evaluation.A device history record review could not be performed as the part and lot number could not be obtained.The original equipment manufacturer (oem) determined that there is no manufacturing, material or processing related cause for this failure mode.A definitive root cause could not be determined of the reported failure due to the following reasons: a) the device was not returned.B) the information provided by the patient does not suggest that the device was damaged or that device migration occurred which supports that this device is mri compatible.With the devices being mri compatible, there should be no reaction of the device if exposed to mri machines and or energy waves from the mri device.The reported push force sensation on the device when crossing the flux lines of the mri, does not indicate damage to the device implanted.Per the surgeon's comment, there has not been a decrease in the patient's hearing that would suggest the device was damaged by being bent and or displaced.As all devices are inspected per dhr review and evaluations of all devices must passed all applicable inspections, it is unlikely the device left the facility damaged.Olympus will continue to monitor the field performance of implant devices.

• Brand Name: SMART STAPES IMPLANT
• Type of Device: SMART 360 PISTON
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: brian motter ; 2925 appling rd; bartlett, TN 38133 ; 4848965250
• MDR Report Key: 13827149
• MDR Text Key: 294375657
• Report Number: 1037007-2022-00006
• Device Sequence Number: 1
• Product Code: ETB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• 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: 06/08/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Male