Hydrodebrider® 1921002Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994712608), received between Mar 17, 2017 and Mar 17, 2017 — classified as 1 injury.

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

• InjuryMar 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER USING THE FUSION AND NUVENT¿ FRONTAL SINUS DILATION BALLOON, THE FRONTAL SINUSES WERE IRRIGATED WITH THE HYDRODEBRIDER. THE PATIENT PRESENTED WITH SWELLING OF THE CONJUNCTIVAL EYELIDS. IRRIGATION WAS STOPPED. THE SURGEON DECOMPRESSED THE PATIENT'S RIGHT EYELID AND REDUCED THE SWELLING BY PERFORMING A LATERAL CANTHOTOMY, TAKING DOWN THE MEDIAL ORBITAL WALL. SINCE THE SWELLING WAS PRE-SEPTAL, THE DOCTOR BELIEVES THAT THE ENTRY OF THE SALINE WAS NOT RELATED TO THE USE OF THE NUVENT OR THE SINUS DISSECTION, BUT BELIEVES THAT THIS PATIENT, WHO HAS A HISTORY OF FACIAL TRAUMA, HAD A PREEXISTING DEHISCENCE OF THE ORBIT THAT WAS TOO SMALL TO SHOW UP IN THE PRE OR POST OPERATIVE CT'S THAT WERE TAKEN. THE PATIENT HAS RECOVERED; THERE ARE NO COMPLICATIONS. THE SURGERY TIME WAS EXTENDED FOR ONE HOUR AS THE ORBITAL DECOMPRESSION WAS ADDED TO THE PROCEDURE, AND AN OPHTHALMOLOGIST WAS CALLED IN TO ASSIST. A POSTOPERATIVE CT CONFIRMED THERE WAS NO FLUID IN THE BRAIN OR REMAINING IN THE RIGHT ORBIT. THE SURGEON CONFIRMED THAT "THE LATERAL CANTHOTOMY AND MEDIAL ORBITAL WALL DECOMPRESSION WERE PREVENTATIVE."

  Patient problems: Eye Injury; Infiltration into Tissue

  MAUDE report 6412900 ↗