NA 826750Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04055207039199), received between May 19, 2020 and Feb 24, 2021 — classified as 1 injury, 2 malfunctions.

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

• InjuryFeb 24, 2021Break; Break

  THE FOLLOWING WAS REPORTED TO RW (B)(4): THE CLAMPED NEEDLE BROKE OFF DURING ADVANCEMENT THROUGH THE LARYNX, WHICH WAS QUITE DIFFICULT TO DO (AT THE REINFORCEMENT ZONE). WHEN WE REMOVED THE INSTRUMENT, WE FOUND THAT PART OF THE NEEDLE HAD BROKEN OFF AND COULD NOT BE FOUND. THUS, WE MUST ASSUME THAT THE MISSING PART OF THE NEEDLE STILL REMAINED IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 11375197 ↗
• MalfunctionDec 17, 2020Positioning Failure; Positioning Failure

  THE FOLLOWING WAS REPORTED TO RW (B)(4): A MICROLARYNGOSCOPY WITH SYNECHIAE TRANSECTION AND INSERTION OF A LACS WAS PLANNED AS SURGERY. AFTER CUTTING THE SYNECHIAE, THE LACS WAS TO BE POSITIONED. FOR THIS PURPOSE, THE THREAD WAS INSERTED INTO THE NEEDLE PROVID-ED FOR THIS PURPOSE AND PUSHED INTO THE NEEDLE SLIDE. POSITIONING OF THE INSTRUMENT AT THE DESIRED LOCATION. THEN THE NEEDLE WAS PUSHED OUT THROUGH THE LARYNX AND THE THREAD WAS FIXED OUTSIDE, THE FIRST SIDE WORKED WELL. WHEN PROCEEDING WITH THE SECOND SIDE, THE NEEDLE COULD BE PRIMARILY RETRACTED INTO THE NEEDLE SLIDE, BUT IN SITUS IT COULD NOT BE PUSHED OUT AGAIN. THE NEEDLE JAMMED IN THE NEEDLE SLIDE, IT ONLY PEEKED OUT A BIT AT THE FRONT. THE NEEDLE COULD NOT BE MOVED AT ALL AND COULD NOT BE REMOVED FROM THE INSTRUMENT. SO THE OPERATION HAD TO BE ABORTED.

  Patient problems: Insufficient Information

  MAUDE report 11030175 ↗
• MalfunctionMay 19, 2020Mechanical Problem; Mechanical Problem

  RICHARD WOLF (B)(4) RECEIVED THE FOLLOWING INFORMATION ON MAY 07, 2020: THE OPERATION " MICROLARYNGOSCOPY AND LATEROFIXATION OF THE VOCAL CORD" COULD NOT BE PERFORMED DUE TO THE MALFUNCTION. CHANGE TO SURGERY WITH CO2 LASER. THE NEEDLE IS VERY DIFFICULT TO PUSH OUT OF THE NEEDLE GUIDE, THEREFORE THE SURGEON HAS TO APPLY HIGH PRESSURE. FURTHERMORE, THE LOCKING OF THE HOLDER DOES NOT WORK WHEN THE NEEDLE IS RETRACTED. A CORRECT LATEROFIXATION COULD NOT BE PERFORMED. CHANGE TO SURGERY WITH CO2 LASER. THERE WAS NO DANGER TO THE PATIENT OR INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10073483 ↗