MAUDE Adverse Event Report: ATOS MEDICAL AB PROVOX VEGA; TRACHEOESOPHAGEAL SPEECH VALVE, INDWELLING

Catalog Number	8283 / 8283-18
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Conclusion product defect cannot be found.Process is in order and clinician followed instructions in the ifu.The prosthesis could have been coming off during transport or at the clinic.The ifu informs to always check that the prosthesis is properly assembled to the inserter pin.Consider discussing with the local atos medical education team.Production records and process reviewed, all in order.Investigation: a loading tube, inserter pin and folding device was returned together with the prosthesis with safety strap still on.The components were disinfected in 70% ethanol prior to investigation.The three loading components are not damaged.On the inserter pin a chewy substance is attached.It is not silicone material, the prosthesis is not damaged and the substance stick together as a lump.The substance is easily split.Silicone oil is present inside the loading tube.The prosthesis is not damaged, is not leaking.When loading the prosthesis with the loading components, the insertion procedure is successfully performed according to instructions in ifu 11468.Root cause not identified.Process in order and clinician followed instructions in ifu.No product error.Discussion: all products are visually inspected several times during production.All operators are trained and instructions are adequate.According to ifu 11468: inspect the package before use.If damaged, do not use the product.Ensure that the prosthesis is properly positioned on the insertion pin with the safety strap in its slot in the insertion pin and the insertion pin all the way into the blue support ring in the prosthesis.Risk assessment rh023, h19: voice prosthesis or parts of it (more than half of the voice prosthesis) extruded into esophagus, need of medical intervention e.G.Esophagoscopy etc.Clinical severity = 6, serious.Trending data does not indicate any unfavorable trends.
Event or Problem Description
The doctor claimed that the vp got dislodged into food path side during the procedure while pulling the loading tube out of the puncture.The safety strap did not function to hook the vp to the insertion pin.The user had a procedure with endoscopy to take the vp out of the food path.Additional information: did they check the safety strap that it was correctly attached? answer: yes, the doctor confirmed it before procedure.Did they need to assembly and reload the provox insertion system? answer: no, they did not.It was not possible to do it actually.The vp was sliding down into the food path for the first attempt.Did they perform an overshooting? answer: no, they did not.They perform the normal replacement.Is it possible to describe what happened during the endoscopy? answer: it was performed just for checking and collecting the dislodged vp.We have sent the vp to you by collecting this procedure.How is the patient today? answer: the patient was fine, indwelled a new one right after the incident.No harm and also no problem on voicing.

• Brand Name: PROVOX VEGA
• Common Device Name: TRACHEOESOPHAGEAL SPEECH VALVE, INDWELLING
• Manufacturer (Section D): ATOS MEDICAL AB; 8 kraftgatan; hörby 24235 ; SW 24235
• Manufacturer (Section G): HÖRBY; 8 kraftgatan; hörby 24235 ; SW 24235
• Manufacturer Contact: sehrbhnu ulrika svensson ; 8 kraftgatan; hörby 24235 ; SW 24235 ; 41519800
• MDR Report Key: 21893402
• Report Number: 8032044-2025-00011
• Device Sequence Number: 15494303
• Product Code: EWL
• UDI-Device Identifier: 07331791010873
• UDI-Public: 07331791010873
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K090455
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/23/2025

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 Catalogue Number: 8283 / 8283-18
• Device Lot Number: 2410233_L828301000
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown