NA 10973HDRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04048551425718), received between Dec 21, 2021 and May 8, 2023 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Sharp Edges” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2023Device Handling Problem; Sharp Edges; Device Handling Problem; Sharp Edges

  IT WAS REPORTED THAT THERE WAS EVENT WITH A 10973HD VIDEO MEDIASTINOSCOPE. THE SURGEON COMPLAINED THAT THIS HD VERSION FELT TO SHARP AT THE TIP AND COMPLAINED ABOUT THE ANGLE AT THE DISTAL PORTION OF THE SCOPE. SURGEON FELT THERE WAS A REAL RISK OF PERFORATING THE TRACHEA. NO PATIENT INJURY, PATIENT UNDER ANESTHESIA, BUT NO INCISION MADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16885815 ↗
• InjuryDec 21, 2021Sharp Edges; Sharp Edges

  AS PER A MANUFACTURER INCIDENT REPORT WE RECEIVED FROM THE FACTORY IN (B)(4): AS REPORTED: "PROF. LEVENT CANSEVER SAID THAT HE WAS PERFORMING A DIAGNOSTIC MEDIASTINOSCOPY AND CONDUCTING A BIOPSY ON TRACHEAL LYMPE NODES, AS A USUAL PROCEDURE FOR HIM, WHILE HE WAS PUSHING FORWARD THE BLADE IN MID-LINE OF THE TRACHEA, HE FELT STRESS ON THE TISSUE THAN HE PUSHED THE BLADE MORE AND THE TRACHEA WAS INJURED. AFTER THIS INCIDENT, HE HAD TO DO OPEN SURGERY FOR TRACHEA REPAIR." (MANUFACTURER'S INTERNAL COMPLAINT # (B)(4)).

  Patient problems: Needle Stick/Puncture

  MAUDE report 13052553 ↗
• InjuryDec 21, 2021Sharp Edges; Sharp Edges

  AS PER A MANUFACTURER INCIDENT REPORT WE RECEIVED FROM THE FACTORY IN (B)(6): AS REPORTED, "TWO INSERTIONS OF THE MEDIASTINOSCOPE EACH RESULTED IN SHEARING OF A LOWER THYROID VEIN WITH SEVERE BLOOD LOSS. " (MANUFACTURER'S INTERNAL COMPLAINT #(B)(4)).

  Patient problems: Needle Stick/Puncture

  MAUDE report 13052548 ↗
• InjuryDec 21, 2021Sharp Edges; Sharp Edges

  AS PER A MANUFACTURER INCIDENT REPORT WE RECEIVED FROM THE FACTORY IN (B)(4): "DURING A MEDIA STINOSCOPY WITH OUR NEWLY PURCHASED VIDEO MEDIASTINOSCOP, APPARENTLY A TRACHEA TEAR HAS OCCURRED DURING THE INSERTION OF THE SCOPE." (MANUFACTURER'S INTERNAL COMPLAINT # (B)(4)).

  Patient problems: Needle Stick/Puncture

  MAUDE report 13052546 ↗
• InjuryDec 21, 2021Sharp Edges; Sharp Edges

  AS PER A MANUFACTURER INCIDENT REPORT WE RECEIVED FROM THE FACTORY IN (B)(4): AS REPORTED: "DUE TO A SHARP EDGE AT THE TIP OF THE SCOPE, THE BRONCHUS OF THE PATIENT WAS RIPPED UPON INTRODUCTION OF THE SCOPE, DAMAGE TO BRONCHUS HAD TO BE SUTURED/REPAIRED" (MANUFACTURER'S INTERNAL COMPLAINT # (B)(4)).

  Patient problems: Needle Stick/Puncture

  MAUDE report 13052545 ↗