MAUDE Adverse Event Report: GYRUS ACMI, INC SMART STAPES PISTON .6 X 4.50 MM; EAR NOSE & THROAT

Model Number	70145928
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for investigation, however, the investigation is still in progress.No conclusion can be determined at this time.If additional information becomes available a supplemental report will be submitted accordingly.
Event or Problem Description
The user facility reported that while a physician performed a stapedectomy, the smart piston did not crimp after two times of heating.The user changed to another new smart piston.The device was not inspected prior to use.A smart piston and thermal handle was also used with this device.The procedure was completed using a new smart thermal tip device.The procedure was prolonged by about 30 minutes.No patient injury was reported.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the device evaluation.Updated fields: b4, g4, g7, h2, h4, h6 and h10.The device was returned for evaluation.It was confirmed a bovie thermal handle and tip were properly working by first testing it on a 70145929, smart stapes piston.6 x 4.75 mm lot# pr923661.When the bovie tip was put in contact with the stapes wire and energized, the stapes loop closed as intended.This confirmed that the thermal handle and tip were working correctly.The returned complaint sample 70145928, lot nc764218 was then submitted to the same test.When the confirmed working bovie thermal handle and tip were put in contact with the wire of the complaint sample and energized, the smart stapes piston properly crimped.The results of this testing indicates that the problem reported by the customer was not associated with the 70145928 smart stapes piston, but was instead most likely related to the equipment used to apply the heat to the smart stapes piston.
Additional Manufacturer Narrative
The device history record (dhr) was reviewed and there were no deviations noted in the dhr.Unit was built per process and operation sequences were listed properly.There was no scrap activity.Pre assembly, post assembly and functional tests were performed.The device passed all functional tests.
Additional Manufacturer Narrative
Correction to g3 of the initial medwatch.The aware date should be 15-aug-2019.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Based on the results of the investigation, the cause is likely non-device related.A definitive root cause cannot be identified.Olympus will continue to monitor the field performance of this device.

• Brand Name: SMART STAPES PISTON .6 X 4.50 MM
• Common Device Name: EAR NOSE & THROAT
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355124
• MDR Report Key: 9038946
• Report Number: 2951238-2019-01115
• Device Sequence Number: 19305742
• Product Code: ETB
• UDI-Device Identifier: 00821925020801
• UDI-Public: 00821925020801
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K003214
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 70145928
• Device Lot Number: NC764218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/15/2019
• Supplement Date Received by Manufacturer: 12/04/2019; 05/29/2020; 06/26/2022
• Initial Report FDA Received Date: 09/13/2019
• Supplement Report FDA Received Date: 02/12/2020; 05/29/2020; 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SMART PISTON 70145928; THERMAL HANDLE 70131012
• Patient Sex: Unknown