Provox Insertion System 22.5Fr 8019Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07331791010729), received between Mar 22, 2017 and Mar 22, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 22, 2017Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  WE HAVE RECEIVED A COMPLAINT FROM (B)(6) IN THE (B)(6) REGARDING A BROKEN INSERTER PIN AT INSERTION. REPRESENTATIVE FROM ATOS MEDICAL (B)(4) HAD A FACE TO FACE MEETING WITH THE SURGEON AND THE SURGEON WENT THROUGH HOW HE HAD USED THE SYSTEM AND EXPLAINED THE CHAIN OF EVENTS AS: LOADING THE VEGA 22.5FR 6MM VOICE PROSTHESES ONTO THE INSERTION PIN OF THE PROVOX INSERTION SYSTEM. ASSEMBLING THE PIN AND THE FOLDING TOOL. OBSERVATION: THE SURGEON DID NOT PULL THE PIN INTO ITS LOCKED POSITION AND STARTED TO PINCH THE TOOL WITH PART OF THE VALVE OUTSIDE THE FOLDING TOOL. HE EXPLAINED THAT HE DID NOT REALLY RECALL HOW HE DID THE PRELOADING BUT THAT HE DID PRELOAD THE VEGA AND ALIGNING THE VALVE WITH THE VISUAL RING OF THE LOADING TUBE. AS THE DISTANCE BETWEEN THE TE PUNCTURE AND THE POSTERIOR ESOPHAGEAL WALL, IN THE PATIENT, WAS QUITE SHORT, HE EXPLAINED THAT HE TRIED TO WIGGLE THE TIP OF THE LOADING TUBE INTO A GOOD POSITION IN THE PUNCTURE. THE VEGA WAS DEPLOYED AND WAS ACCIDENTLY OVERSHOT. THE INSERTER PIN WAS REMOVED IN A RAPID SIDEWAYS MOVEMENT. USING TWO HEMOSTATS, THE TRACHEAL FLANGE OF THE VEGA WAS GRASPED WITH ONE HEMOSTAT AND THE OTHER WAS USED TO SLOWLY ROTATING THE VALVE BACK IN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6423650 ↗