EndoStat 0010-0612Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00878953000077), received between Aug 28, 2017 and Oct 28, 2021 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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. 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.

• InjuryOct 28, 2021Break; Break

  IT WAS REPORTED THAT DURING A SUBGLOTTIC DILATION LARYNGOSCOPY PROCEDURE, THE FIBER BROKE INSIDE THE PATIENT. UPON REMOVAL OF THE FIBER FROM THE PATIENT BODY, IT WAS OBSERVED THAT 3.5CM WERE MISSING. THE OPERATING ROOM STAFF FOLLOWED PROTOCOL TO RETAIN FOREIGN OBJECT BY PERFORMING AN X-RAY. IN ADDITION THEY RE-EXAMINED WITH A GLIDESCOPE, CHECKED THE SUCTION TUBING, AND CANISTER BUT THE MISSING FRAGMENT WAS NOT FOUND. THE CASE WAS COMPLETED BY PERFORMING TEMPORARY TRACHEOSTOMY. THE PATIENT HAS ALREADY BEEN DISCHARGED.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 12716320 ↗
• InjuryApr 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A FLEXIBLE FIBEROPTIC BRONCHOSCOPY WITH LAVAGE, WITH ENDOBRONCHIAL ULTRASOUND-GUIDED FINE-NEEDLE ASPIRATION (EBUS-FNA), ENDOBRONCHIAL BIOPSIES, AND POTASSIUM-TITANYL-PHOSPHATE CRYSTAL (KTP) LASER DEBRIDEMENT OF A RIGHT MAINSTEM TUMOR. DURING PROCEDURE, A REGULAR BRONCHOSCOPE WAS INSERTED AND ENDOBRONCHIAL BIOPSIES WERE TAKEN OF THE RIGHT MAIN STEM MASS. THE PATIENT WAS THEN PREPARED FOR LASER DEBRIDEMENT OF THE AIRWAY TUMOR. THE ENDOTRACHEAL TUBE (ETT) WAS POSITION HALF WAY DOWN THE TRACHEA AND SECURED ABOUT "1O CM" FROM THE CARINA. THE LASER WAS THEN INSERTED INTO THE AIRWAY. THE PROXIMAL END OF THE LESION WAS TREATED WITH ONE SECOND 15 WATT PULSES OF ENERGY. THE LASER WAS THEN REMOVED TO ALLOW FOR SUCTIONING OF DEBRIS AND BLOOD. THE PATIENT WAS THEN NOTED WITH SMOKE COMING FROM THE AIRWAY WITH LOSS OF VISUALIZATION ON THE SCREEN. THE SCOPE WAS REMOVED AND INSPECTED WITH DAMAGE NOTED TO THE DISTAL END. THE ETT WAS IMMEDIATELY REMOVED. THE PATIENT UNDERWENT BAG MASK VENTILATION AND WAS REINTUBATED WITH A 9.0 ETT. A NEW BRONCHOSCOPE WAS THEN INSERTED AND THE AIRWAY WAS INSPECTED IN DETAIL. THERE WAS EVIDENCE OF THERMAL INJURY THROUGHOUT THE AIRWAY AND BLAC

  Patient problems: Airway Obstruction; Blood Loss; Burn, Thermal

  MAUDE report 7389328 ↗
• MalfunctionAug 28, 2017Break; Material Fragmentation; Device Or Device Fragments Location Unknown; Break; Material Fragmentation; Device Or Device Fragments Location Unknown

  IT WAS REPORTED THAT AT THE COMPLETION OF A DIAGNOSTIC LAPAROSCOPY PROCEDURE, A PIECE OF THE FIBER BROKE OFF INTO THE PATIENT AND WAS NEVER LOCATED TO BE REMOVED. THERE WAS NO PATIENT ISSUES" REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6823462 ↗