MAUDE Adverse Event Report: ATOS MEDICAL AB PROVOX ACTIVALVE LIGHT 6 MM; VOICE PROSTHESIS

Catalog Number	7151
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: the investigation shows that the safety strap is intact and the silicone material of the housing has been stressed close to the esophagus flange at the hinge side.The flat surface of the entrance opening of the loading tube is deformed and a have a dome shape compared to an undamaged tube.The fact that the valve flap is dislodged from the blue ring is most likely a result from a non-forward folding of the voice prosthesis esophagus flange.These observations indicate that abnormal stress has been applied to material and components.Conclusion/action: it is very unlikely that the insertion is performed according to the ifu based on the observations above.The clinician should be instructed to follow the ifu to secure a proper handling when inserting the activalve.Trend analysis: trend for this issue is judged as stabile.A more extensive analysis is done twice a year for the management review.Corrective and preventive action: no product fault, no reason for corrective or preventive actions.Patient risk associated with this complaint is considered negligible based on the fact that all parts were returned.
Event or Problem Description
This is the information that was received from the atos medical local representative: when the doctor inserted the activalve with the patient, the entire blue inside (including the valve) let loose and fell.The doctor could reach for it with a tweezer, before it had a chance to fell into the patient lungs.Our product specialist was there and watched the insertion and everything was done according the ifu.They had to make a ct scan and mri, to check where his previous voice prosthesis was (probably swallowed it), so they could immediately check if really nothing fell into the lungs.After this another activalve was placed and there were no problems.Device has been returned and investigated.(b)(6) 2017.

• Brand Name: PROVOX ACTIVALVE LIGHT 6 MM
• Common Device Name: VOICE PROSTHESIS
• Manufacturer (Section D): ATOS MEDICAL AB; kraftgatan 8; horby, SE-24 222; SW SE-24222
• MDR Report Key: 6416662
• Report Number: 8032044-2017-00002
• Device Sequence Number: 37026
• Product Code: EWL
• UDI-Device Identifier: 07331791000539
• UDI-Public: 7331791000539
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K092593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 7151
• Device Lot Number: 1608166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2017
• Device Age: 6 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2017
• Initial Report FDA Received Date: 03/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1