AIRWAY MOBILESCOPE OLYMPUS MAF TYPE TMRecalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 04953170288630), received between Feb 15, 2022 and Aug 11, 2026 — classified as 43 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (38 reports).

2 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

1. Sep 25, 2023Class IIOpen, Classified

   Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection

   Z-0340-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Jul 27, 2023Class IIOpen, Classified

   Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.

   Z-2495-2023 · Root cause: Labeling Change Control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Image Display Error/Artifact

  No additional information received from customer

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50214122 ↗
• MalfunctionApr 10, 2026No Display/Image

  THE AIRWAY MOBILESCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF FAILED LEAK TEST AND CRACK AT HINGE OF SCREEN. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, NO IMAGE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24840503 ↗
• MalfunctionOct 7, 2024Peeled/Delaminated; Failure to Clean Adequately; Peeled/Delaminated; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE MOBILESCOPE EXHIBITED THE INSERTION SECTION OF THE FLEXIBLE TUBE COATING PEELED OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20389283 ↗
• MalfunctionSep 12, 2024Peeled/Delaminated; Failure to Clean Adequately; Peeled/Delaminated; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE AIRWAY MOBILESCOPE HAD FOREIGN MATERIAL IN THE FORCEPS CHANNEL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20201790 ↗
• MalfunctionAug 21, 2024Peeled/Delaminated; Peeled/Delaminated

  DURING DEVICE EVALUATION, IT WAS OBSERVED THE AIRWAY MOBILESCOPE EXHIBITED PEELING OF THE CONNECTING TUBE COATING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20015115 ↗
• MalfunctionAug 14, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE AIRWAY MOBILESCOPE EXHIBITED THE IMAGE GUIDE TUBE PEELED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19980642 ↗
• MalfunctionMay 15, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COATING WAS PEELING ON THE IMAGE GUIDE TUBE OF THE VIDEOSCOPE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19324105 ↗
• MalfunctionJan 31, 2024Peeled/Delaminated; Peeled/Delaminated

  DURING THE DEVICE EVALUATION, IT WAS OBSERVED THE AIRWAY MOBILESCOPE EXHIBITED PEELING OF THE CONNECTING TUBE COATING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18615876 ↗
• MalfunctionJan 5, 2024Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS, THE AIRWAY MOBILESCOPE HAD AN IMAGE DEFECT, WAS INOPERABLE AND SEPARATING. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THIS EVENT. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: THE IMAGE GUIDE TUBE COAT WAS PEELING. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18451789 ↗
• MalfunctionDec 12, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS, THE AIRWAY MOBILESCOPE HAD LEAKAGE FROM THE INSERTION SECTION. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: THE CONNECTING TUBE HAD COATING PEELING (1 TO 2 OR MORE MILLIMETERS). THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18315640 ↗
• MalfunctionDec 11, 2023Peeled/Delaminated; Peeled/Delaminated

  AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS ON BEHALF OF THE CUSTOMER THAT THE AIRWAY MOBILESCOPE HAD AN ISOLATED LEAK. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: THE COAT OF THE IMAGE GUIDE PIPE WAS PEELING OFF (1MM2 OR MORE). THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THE EVENT. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18307409 ↗
• MalfunctionNov 19, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS, THE AIRWAY MOBILESCOPE COULD NOT ANGULATE SUFFICIENTLY. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, IT WAS OBSERVED THAT THE COATING OF THE IMAGE GUIDE PIPE WAS PEELING OFF (1 MILLIMETER (MM) TO 2MM OR MORE). THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18167323 ↗
• MalfunctionOct 24, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS, THE AIRWAY MOBILESCOPE TIP OF THE BENDING SECTION COVER WAS LOOSE. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: THE CONNECTING TUBE HAD COATING PEELING (1MM2 OR MORE). THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17995060 ↗
• MalfunctionOct 19, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER INITIALLY REPORTED TO OLYMPUS THAT THE AIRWAY MOBILESCOPE HAD PINHOLES. THERE WERE NO REPORTS OF PATIENT HARM. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS IDENTIFIED: THE INDICATION ON CONNECTING TUBE HAD A DISAPPEARED AREA (1MM SQUARED OR MORE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17966649 ↗
• MalfunctionSep 19, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS THAT AIRWAY MOBILESCOPE'S LIGHT GUIDE BUNDLE SHOWED BREAKAGE. THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. DURING EVALUATION, CONNECTING TUBE SHOWED THE COATING WAS PEELING AND HAD A MISSING INDICATOR. THIS MEDICAL DEVICE REPORT (MDR)IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION. NO ADVERSE EFFECTS TO PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17777704 ↗
• MalfunctionSep 18, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS, THE AIRWAY MOBILESCOPE WAS CAUGHT IN THE FORCEPS CHANNEL. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: THE CONNECTING TUBE COATING WAS PEELING (1MM SQUARED OR MORE). THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17765146 ↗
• MalfunctionSep 8, 2023Peeled/Delaminated; Peeled/Delaminated

  A USER FACILITY SUBMITTED A REPAIR REQUEST TO THE OLYMPUS SERVICE CENTER, FOR AN AIRWAY MOBILESCOPE HAVING BAD OUTPUT. UPON INSPECTION AND TESTING OF THE CUSTOMER RETURNED DEVICE, THE COATING ON THE SCOPE IMAGE GUIDE SERPENTINE TUBE WAS FOUND PEELED OFF (1 TO 2 MM OR MORE). THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION. THERE WAS NO REPORT OF PATIENT HARM OR USER INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17713023 ↗
• MalfunctionSep 7, 2023Peeled/Delaminated; Peeled/Delaminated

  AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS ON BEHALF OF THE CUSTOMER THAT THE AIRWAY MOBILESCOPE HAD BLACK SPOTS ON THE IMAGE. THE ISSUE WAS FOUND DURING REPROCESSING AFTER THE INTENDED DIAGNOSTIC BRONCHIAL EXAMINATION PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH THE SAME EQUIPMENT. THERE WAS NO DELAY, AND THE PATIENT WAS NOT UNDER ANESTHESIA. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: THE COATING ON THE INSERTION SECTION PEELED OFF. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17707046 ↗
• MalfunctionAug 25, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE OLYMPUS REPRESENTATIVE REPORTED (ON BEHALF OF THE CUSTOMER) THAT THE AIRWAY MOBILESCOPE HAD A COMPROMISED IMAGE. THERE WERE NO REPORTS OF PATIENT HARM. DURING EVALUATION OF THE RETURNED DEVICE, IT WAS FOUND THAT A FOREIGN OBJECTS CAME OUT OF FORCEPS CHANNEL AND THEREFORE IS CONSIDERED A MEDICAL DEVICE REPORT (MDR). THIS MDR IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17627766 ↗
• MalfunctionJul 14, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE AIRWAY MOBILESCOPE HAD SPOTS IN THE IMAGE AND BROKEN FIBERS. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: THE CONNECTING TUBE HAD COATING PEELING. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17325785 ↗
• MalfunctionJun 8, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS THE AIRWAY MOBILESCOPE EXHIBITED A LEAK DUE TO PINHOLES IN THE BENDING RUBBER (THE METAL WAS NOT STICKING OUT). THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THIS EVENT. DURING TESTING AND INSPECTION OF THE RETURNED DEVICE REVEALED THAT THE COATING OF THE SCOPE INSERTION GUIDE SERPENTINE WAS PEELING OFF. (1MM2 OR MORE). THIS HAD BEEN ATTRIBUTED DUE TO STRESS OF REPEATED USE, DETERIORATION, EXTERNAL FACTORS, OR HANDLING. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17094836 ↗
• MalfunctionApr 23, 2023Peeled/Delaminated; Peeled/Delaminated

  THE DISTRIBUTOR REPORTED TO OLYMPUS MEDICAL ON BEHALF OF THE CUSTOMER THAT THE AIRWAY PORTABLE MOBILESCOPE HAD DEFECTS AT THE BENDING SECTION AND INSERTION TUBE. THE DEVICE WAS RETURNED TO OLYMPUS MEDICAL FOR EVALUATION. DURING INSPECTION, THE INSERTION SECTION WAS FOUND TO HAVE AN AREA OF COATING PEELED OFF THAT MEASURED AT LEAST 1 SQUARE MILLIMETER. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16792875 ↗
• MalfunctionApr 19, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS, THAT THE AIRWAY MOBILESCOPE EXHIBITED A LEAK. NO PATIENT HARM WAS REPORTED IN RELATION TO THIS EVENT. THE SUBJECT DEVICE WAS SUBSEQUENTLY RETURNED TO OLYMPUS AND EVALUATED. THE EVALUATION REVEALED THAT THE CORRUGATED PIPE COAT ON THE DEVICE WAS PEELING. THE IMAGE GUIDE (IG) TUBE WAS ALSO PEELING. THIS MDR (MEDICAL DEVICE REPORT) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16773797 ↗
• MalfunctionApr 19, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE AIRWAY MOBILESCOPE HAD A BENDING SECTION PINHOLE. DURING INSPECTION AND EVALUATION, A FOREIGN OBJECT CAME OUT OF THE FORCEPS CHANNEL. THERE WAS NO REPORT OF PATIENT HARM OR USER INJURY ASSOCIATED WITH THIS EVENT. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTIONS FOUND DURING INCOMING INSPECTION AND EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16770794 ↗
• MalfunctionApr 12, 2023Peeled/Delaminated; Peeled/Delaminated

  THE AIRWAY MOBILESCOPE WAS SENT TO AN OLYMPUS SERVICE CENTER FOR EVALUATION AFTER BEING RETURNED FROM THE END USER WITH NO COMPLAINT. UPON INSPECTION OF THE CUSTOMER¿S RETURNED DEVICE IT WAS OBSERVED, THE IMAGE GUIDE TUBE COAT WAS PEELING. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16723872 ↗