AVS NAVIGATOR 48392080Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613252252207), received between Jun 17, 2016 and Jun 17, 2016 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2016Failure to Form Staple; Device Dislodged or Dislocated

  IT WAS REPORTED THAT; FIRST IMPLANT WAS USED WITH BAYONETTED INSERTER AND CAME DISLODGED WHEN INSERTING. RAIL ON IMPLANT APPEARED MALFORMED AND WAS NOT REATTACHED. SURGEON THEN ATTEMPTED TO PLACE DIFFERENT IMPLANT ON STRAIGHT INSERTER AND EXPERIENCED THE SAME OUTCOME. PER SURGEON, NO PATIENT ADVERSE EVENT RESULTED FROM IMPLANTS BEING DISLODGED. SURGEON DID NOT ATTEMPT TO PLACE A THIRD IMPLANT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5732126 ↗
• MalfunctionJun 17, 2016Mechanical Problem; Device Dislodged or Dislocated; Mechanics Altered; Mechanical Problem

  IT WAS REPORTED THAT; FIRST IMPLANT WAS USED WITH BAYONETTED INSERTER AND CAME DISLODGED WHEN INSERTING. RAIL ON IMPLANT APPEARED MALFORMED AND WAS NOT REATTACHED. SURGEON THEN ATTEMPTED TO PLACE DIFFERENT IMPLANT ON STRAIGHT INSERTER AND EXPERIENCED THE SAME OUTCOME. PER SURGEON, NO PATIENT ADVERSE EVENT RESULTED FROM IMPLANTS BEING DISLODGED. SURGEON DID NOT ATTEMPT TO PLACE A THIRD IMPLANT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 5732103 ↗