n.a. 10366SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048551046982), received between Apr 11, 2026 and Apr 11, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Separation” (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 18, 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.

• InjuryApr 11, 2026Material Separation

  THE FOLLOWING WAS REPORTED: ON SUNDAY EVENING, DURING AN ESOPHAGEAL FOREIGN BODY OPERATION, AN OTOLARYNGOLOGIST USED AN ESOPHAGOSCOPE FINE SCISSORS TO CUT A FISHBONE IN THE ESOPHAGUS. THE SCISSORS MALFUNCTIONED DURING USE. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS, THE FINE SCISSORS WERE REMOVED FROM THE PATIENT'S BODY AND TESTED ON A SURGICAL DRAPE, WHICH THEY ALSO FAILED TO CUT. THE SCISSORS WERE THEN PLACED ON THE SURGICAL INSTRUMENT CART. AFTER THE OPERATION WAS COMPLETED, THE NURSE FOUND THE INSTRUMENT TO BE ABNORMALLY SHAPED DURING INSTRUMENT RETRIEVAL AND SUSPECTED A DEFECT. SHE INSTRUCTED THE ON-DUTY NURSE TO KEEP THE INSTRUMENT FOR FURTHER VERIFICATION THE NEXT WORKDAY. BY THIS TIME, THE PATIENT HAD BEEN SAFELY RETURNED TO THE WARD. ON MONDAY, THE INSTRUMENT NURSE COMPARED THE ODDLY SHAPED INSTRUMENT WITH PHOTOS TAKEN DURING INSTRUMENT PACKAGING AND CONFIRMED THAT THE DISTAL TIP OF THE SCISSORS HAD BROKEN OFF. THE ON-DUTY SURGICAL NURSE AND OPERATING SURGEON WERE IMMEDIATELY NOTIFIED, THE SURGICAL COURSE WAS REVIEWED, AND THE INCIDENT WAS REPORTED ALTHOUGH THE BROKEN TIP HAS NOT BEEN RECOVERED, RETENTION OF THE FRAGMENT INSIDE THE PATIENT HAS BEEN RULED OUT. DUE TO THE UNKNOWN W

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24850210 ↗
• InjuryApr 11, 2026Material Separation

  THE FOLLOWING WAS REPORTED: ON SUNDAY EVENING, DURING AN ESOPHAGEAL FOREIGN BODY OPERATION, AN OTOLARYNGOLOGIST USED AN ESOPHAGOSCOPE FINE SCISSORS TO CUT A FISHBONE IN THE ESOPHAGUS. THE SCISSORS MALFUNCTIONED DURING USE. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS, THE FINE SCISSORS WERE REMOVED FROM THE PATIENT'S BODY AND TESTED ON A SURGICAL DRAPE, WHICH THEY ALSO FAILED TO CUT. THE SCISSORS WERE THEN PLACED ON THE SURGICAL INSTRUMENT CART. AFTER THE OPERATION WAS COMPLETED, THE NURSE FOUND THE INSTRUMENT TO BE ABNORMALLY SHAPED DURING INSTRUMENT RETRIEVAL AND SUSPECTED A DEFECT. SHE INSTRUCTED THE ON-DUTY NURSE TO KEEP THE INSTRUMENT FOR FURTHER VERIFICATION THE NEXT WORKDAY. BY THIS TIME, THE PATIENT HAD BEEN SAFELY RETURNED TO THE WARD. ON MONDAY, THE INSTRUMENT NURSE COMPARED THE ODDLY SHAPED INSTRUMENT WITH PHOTOS TAKEN DURING INSTRUMENT PACKAGING AND CONFIRMED THAT THE DISTAL TIP OF THE SCISSORS HAD BROKEN OFF. THE ON-DUTY SURGICAL NURSE AND OPERATING SURGEON WERE IMMEDIATELY NOTIFIED, THE SURGICAL COURSE WAS REVIEWED, AND THE INCIDENT WAS REPORTED ALTHOUGH THE BROKEN TIP HAS NOT BEEN RECOVERED, RETENTION OF THE FRAGMENT INSIDE THE PATIENT HAS BEEN RULED OUT. DUE TO THE UNKNOWN W

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24850208 ↗