• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

GYRUS ACMI, INC SMART 360 PISTON .5MM X 4.50MM; PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10373216
MDR Text Key207375589
Report Number1037007-2020-00030
Device Sequence Number1
Product Code ETB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K003214
Number of Events Reported1
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
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number70143655
Device Lot NumberPR868415
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/08/2020
Initial Date FDA Received08/06/2020
Supplement Dates Manufacturer Received11/02/2020
06/23/2022
Supplement Dates FDA Received11/17/2020
07/15/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/10/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-