MAUDE Adverse Event Report: SMART STAPES PISTON .6 X 4.50 MM

Model Number 70145928

Device Problem Material Deformation (2976)

Patient Problem Partial Hearing Loss (4472)

Event Date 07/01/2022

Event Type  malfunction  

Event Description

It was reported the patient received a smart piston implant which crimped both during and post procedure resulting in another procedure at another date.According to the report, the problem found when the user used it for a patient who had undergone stapedectomy on (b)(6) 2022.According to the report, during the procedure, customer had to open a second implant as the first one crimped back.However, later on, this patient came in for a revision stapededtomy on (b)(6) 2022 and same issue was observed.The customer replaced the implant with big easy (third party device).According to the report, patient had the stapedectomy on the other side on (b)(6) 2022 and a big easy piston was used for the procedure.The intended procedure was completed.No injury or harm was reported.This event includes two reports.Report with patient identifier (b)(6) smart piston model 70145928 lot sm960548 - crimped smart piston (during procedure and was replaced with second smart piston).Report with patient identifier (b)(6) smart piston model 70145928 lot pr966762.Crimped smart piston (fully implanted).Observed on (b)(6) 2022 during the revision procedure.Report with patient identifier (b)(6) smart piston model 70145928 lot pr966762.Crimped smart piston (fully implanted).

Manufacturer Narrative

The subject device was not returned as the device was discarded by the customer.The cause of the reported issue is unknown at this time.Investigation is ongoing.This report will be supplemented accordingly following investigation.

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 2 years since the subject device was manufactured.Based on the results of the investigation, the definitive root case of the implant crimping and/or failing post-procedure could not be determined.It is likely that the implants left the manufacturing facility undamaged.The damages likely occurred during transportation or during customer use.The event can be detected/prevented by following the instructions for use (ifu) which state: "by the use of a low temperature (65° c) heating device.Once the loops have been placed around the incus or malleus, the low temperature heating device may be positioned so that the tip is in near proximity to the loops on the incus or malleus.At a distance of 0.5 mm to 1 mm, the heat generated by the low temperature heating device is sufficient to activate the closing of the wire loops." this supplemental report includes information added to g2.Olympus will continue to monitor field performance for this device.

• Brand Name: SMART STAPES PISTON .6 X 4.50 MM
• Type of Device: SMART STAPES PISTON
• Manufacturer Contact: todd brill ; 2925 appling rd; bartlett, TN 38133 ; 5082077661
• MDR Report Key: 15522963
• MDR Text Key: 302354241
• Report Number: 1037007-2022-00020
• Device Sequence Number: 1
• Product Code: ETB
• UDI-Device Identifier: 00821925020801
• UDI-Public: 00821925020801
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K003214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70145928
• Device Lot Number: PR966762
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1