AESCULAP MA922RRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046964686238), received between Dec 23, 2020 and Dec 23, 2020 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 23, 2020Break; Break

  IT WAS REPORTED TO AESCULAP THAT A CRAWFORD INTUBATION SET (PART # (B)(4) WAS USED DURING A NASOLACRIMAL DUCT INTUBATION PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE STYLET REPORTEDLY DETACHED. REPORTEDLY, THE STYLET DETACHED FROM THE TUBING PASSING THROUGH THE CANAL; BY THE TIME THE TUBE WAS FAR ENOUGH TO GRASP, THE STYLET WAS DETACHED. THE SURGEON NOTED THAT THE STYLETS APPEAR TO BE FURTHER OUT OF THE TUBE WHEN BEGINNING TO PLACE. THE DEVICES ARE POPPING OUT; NO VISIBLE DAMAGE TO TUBING WAS OBSERVED, IT SIMPLY SEPARATED. THE DEVICE WAS DISCARDED, THEREFORE, IT IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT YET BEEN MADE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11068770 ↗
• InjuryDec 23, 2020Break; Break

  IT WAS REPORTED TO AESCULAP THAT A CRAWFORD INTUBATION SET (PART # MA922R) WAS USED DURING A NASOLACRIMAL DUCT INTUBATION PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE STYLET REPORTEDLY DETACHED. REPORTEDLY, THE STYLET DETACHED FROM THE TUBING PASSING THROUGH THE CANAL; BY THE TIME THE TUBE WAS FAR ENOUGH TO GRASP, THE STYLET WAS DETACHED. THE SURGEON NOTED THAT THE STYLETS APPEAR TO BE FURTHER OUT OF THE TUBE WHEN BEGINNING TO PLACE. THE DEVICES ARE POPPING OUT; NO VISIBLE DAMAGE TO TUBING WAS OBSERVED, IT SIMPLY SEPARATED. THE DEVICE WAS DISCARDED, THEREFORE, IT IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT YET BEEN MADE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11068717 ↗
• MalfunctionDec 23, 2020Break; Break

  IT WAS REPORTED TO AESCULAP THAT A CRAWFORD INTUBATION SET (PART # MA922R) WAS USED DURING A MEETING WITH THE SALES REPRESENTATIVE TO INSPECT AND FUNCTIONALLY TEST THE DEVICE. ACCORDING TO THE COMPLAINANT, A NEW DEVICE THAT HAD BEEN PROCESSED WAS USED AS AN EXAMPLE, AND UPON PULLING THE STYLET, IT DETACHED AND THE TUBING BROKE. THE DEVICE WAS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT YET BEEN MADE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11068668 ↗