Ambu® aScope™ 5 Broncho 2.7/1.2 624001000USRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05707480157280), received between Nov 22, 2024 and Dec 8, 2025 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A VATS SURGICAL PROCEDURE THAT OUR A5 2.7MM ENDOSCOPE DISTAL TIP BROKE OFF INTO THE PATIENTS ENDOTRACHEAL TUBE. ANESTHESIA TEAM WENT IN AND RETRIEVED THE PIECE THAT HAD BROKEN OFF. PATIENT CONDITION WAS NOT AFFECTED BY THE FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23748072 ↗
• InjuryDec 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A VATS SURGICAL PROCEDURE THAT OUR A5 2.7MM ENDOSCOPE DISTAL TIP BROKE OFF INTO THE PATIENTS ENDOTRACHEAL TUBE. ANESTHESIA TEAM WENT IN AND RETRIEVED THE PIECE THAT HAD BROKEN OFF. PATIENT CONDITION WAS NOT AFFECTED BY THE FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23740214 ↗
• MalfunctionJan 7, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A CLINICIAN ACCUSTOMED TO PIERCING THE WHITE RUBBER COVER OF THE WORKING CHANNEL OF ASCOPE 5 BRONCHO WITH A SYRINGE, IN ORDER TO ACCESS THE WORKING CHANNEL, REPORTED THAT A PIECE OF WHITE RUBBER DISLODGED FROM ASCOPE 5 BRONCHO AND FLUSHED DOWN IN THE WORKING CHANNEL DURING BRONCHOSCOPY. THE INCIDENT INVOLVED A PATIENT, BUT DID NOT LEAD TO PATIENT HARM, AS THE USER WAS ABLE TO SUCTION THE RUBBER PIECE UP INTO THE SPECIMEN TRAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21092218 ↗
• MalfunctionJan 7, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A CLINICIAN ACCUSTOMED TO PIERCING THE WHITE RUBBER COVER OF THE WORKING CHANNEL OF ASCOPE 5 BRONCHO WITH A SYRINGE, IN ORDER TO ACCESS THE WORKING CHANNEL, REPORTED THAT A PIECE OF WHITE RUBBER DISLODGED FROM ASCOPE 5 BRONCHO AND FLUSHED DOWN IN THE WORKING CHANNEL DURING BRONCHOSCOPY. THE INCIDENT INVOLVED A PATIENT, BUT DID NOT LEAD TO PATIENT HARM, AS THE USER WAS ABLE TO SUCTION THE RUBBER PIECE UP INTO THE SPECIMEN TRAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21088770 ↗
• MalfunctionNov 22, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED BY THE CUSTOMER THAT TWO ASCOPE 5 BRONCHO ULTRA-THIN SCOPE WOULD NOT ALLOW PASSAGE OF ERBE CRYOPROBE THROUGH WORKING CHANNEL. DURING A ROUTINE CRYO PROCEDURE WITH OUR A5 ULTRA-THIN SCOPE THE STAFF HAD NO PROBLEM PASSING THE PROBE THOUGH THE WORKING CHANNEL UNTIL THE END OF THE CHANNEL WHERE RESISTANCE WAS FELT, AND THE PROBE WOULD NOT PASS THROUGH THE END OF SCOPE RESULTING IN KINKING THE PROBE. THE STAFF THEN SWITCHED TO A NEW A5 ULTRA-THIN SCOPE FROM A DIFFERENT BOX WITH THE SAME LOT NUMBER AS WELL AS A NEW CRYOPROBE. THE PHYSICIAN ALSO REMOVED THE SCOPE FROM THE PATIENT MAKING SURE THE SCOPE WAS COMPLETELY STRAIGHT AND THE PROBLEM STILL OCCURRED AGAIN. AFTER THE SECOND TIME THE STAFF SWITCHED TO A REUSABLE OLYMPUS SCOPE, AND THEY HAD NO PROBLEM PASSING THE CRYOPROBE. THE SCOPES CAME FROM TWO DIFFERENT BOXES/ AREAS BUT HAD THE SAME LOT NUMBER. THE PROCEDURE IS CATEGORIZED AS OFF-LABEL, SINCE ASCOPE 5 BRONCHO WAS USED ON A PEDIATRIC PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20760784 ↗
• MalfunctionNov 22, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED BY THR CUSTOMER THAT TWO SCOPE 5 BRONCHO ULTRA-THIN SCOPE WOULD NOT ALLOW PASSAGE OF ERBE CRYOPROBE THROUGH WORKING CHANNEL. DURING A ROUTINE CRYO PROCEDURE WITH OUR A5 ULTRA-THIN SCOPE THE STAFF HAD NO PROBLEM PASSING THE PROBE THOUGH THE WORKING CHANNEL UNTIL THE END OF THE CHANNEL WHERE RESISTANCE WAS FELT, AND THE PROBE WOULD NOT PASS THROUGH THE END OF SCOPE RESULTING IN KINKING THE PROBE. THE STAFF THEN SWITCHED TO A NEW A5 ULTRA-THIN SCOPE FROM A DIFFERENT BOX WITH THE SAME LOT NUMBER AS WELL AS A NEW CRYOPROBE. THE PHYSICIAN ALSO REMOVED THE SCOPE FROM THE PATIENT MAKING SURE THE SCOPE WAS COMPLETELY STRAIGHT AND THE PROBLEM STILL OCCURRED AGAIN. AFTER THE SECOND TIME THE STAFF SWITCHED TO A REUSABLE OLYMPUS SCOPE, AND THEY HAD NO PROBLEM PASSING THE CRYOPROBE. THE SCOPES CAME FROM TWO DIFFERENT BOXES/ AREAS BUT HAD THE SAME LOT NUMBER. THE PROCEDURE IS CATEGORIZED AS OFF-LABEL, SINCE A SCOPE 5 BRONCHO WAS USED ON A PEDIATRIC PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20757475 ↗