MAUDE Adverse Event Report: GYRUS ACMI, INC SMART 360 PISTON .5MM X 4.50MM; PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT

Model Number 70143655

Device Problem Sparking (2595)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/08/2020

Event Type  malfunction  

Manufacturer Narrative

Device has not been returned for evaluation.The customer¿s complaint was not confirmed.No findings available.The cause could not be determined.No further information was reported.

Event Description

It was reported to olympus that at end of a therapeutic stapedotomy procedure, the physician hit the piston with a diode laser and it sparked.The nitinol portion of the prothesis vaporized.The physician removed the piston under a microscope and confirmed the entire piston was retrieved.The intended procedure was completed with the same equipment.There was a five minute delay while patient was under general anesthesia.There was no patient injury reported.

Manufacturer Narrative

This supplemental report was submitted to provide additional information to mdr# 1037007-2020-00030.The device was not returned for a physical inspection.The original equipment manufacturer (oem) performed a device history record review for product with lot # pr868415 and no abnormalities were noted.An investigation was completed by the oem and determined that there is no manufacturing, material or processing related cause for this failure mode.The root cause could not be determined as the device was not returned for inspection.However, based on follow-up communication with the medical facility personnel, it was noted that "he [surgeon] hit it with a laser and it sparked.The nitinol portion of the prothesis vaporized".This suggests that a laser was used to heat the piston.Per the instructions for use, a low temperature heating device should be used to activate the crimp.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.5 mm to 1 mm, the heat generated by the low temperature heating device is sufficient to activate the closing of the wire loops.By touching the tip of a bipolar cautery to the wire loops and applying electrical energy of approximately 10 watts.Heat energy transfer occurs best when the incus or malleus is first moistened with a few drops of saline.A setting of greater than 10 watts for the bipolar cautery increases the likelihood that damage to the surrounding mucosa may occur.Precautions: care should be taken.Olympus will continue to monitor the field performance of this device.

• Brand Name: SMART 360 PISTON .5MM X 4.50MM
• Type of Device: PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: kenneth pittman ; 2925 appling rd; bartlett, TN 38133 ; 9013785969
• MDR Report Key: 10373216
• MDR Text Key: 207375589
• Report Number: 1037007-2020-00030
• Device Sequence Number: 1
• Product Code: ETB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70143655
• Device Lot Number: PR868415
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2019
• 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