AIRWAY MOBILESCOPE OLYMPUS MAF-GM2Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 04953170407208), received between Feb 28, 2022 and Mar 10, 2026 — classified as 2 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (24 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-2499-2023 · Root cause: Labeling Change Control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2026Poor Quality Image

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE AIRWAY MOBILESCOPE WAS UNABLE TO CHECK THE IMAGE, AS THE SCOPE WOULD NOT POWER ON. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24563896 ↗
• MalfunctionJan 2, 2026No Display/Image

  IT WAS OBSERVED THAT DURING THE EVALUATION, THE AIRWAY MOBILESCOPE EXHIBITED THAT THERE WAS NO IMAGE ON THE SCREEN. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23952235 ↗
• MalfunctionAug 4, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS OBSERVED DURING THE DEVICE EVALUATION THAT THE MOBILESCOPE EXPERIENCED A TEAR IN THE FORCEPS CHANNEL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22709997 ↗
• MalfunctionNov 8, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE AIRWAY MOBILESCOPE EXHIBITED FOREIGN OBJECTS IN THE FORCEPS CHANNEL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20642585 ↗
• InjuryOct 10, 2024Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT DURING A THERAPEUTIC LUNG RESECTION PROCEDURE, USING AIRWAY MOBILESCOPE, THERE WAS NO MOVING IMAGE ON THE SCREEN AND BAD QUALITY IMAGE WAS PRODUCED. NO ERROR MESSAGE WAS PRODUCED. THE PROCEDURE WAS REPORTED TO BE EXTENDED FOR 1 HOUR WHILE THE PATIENT WAS SEDATED, AND THE PROCEDURE TRIED ON A BACKUP OLYMPUS SCOPE WITH A (DIFFERENT MODEL WAS USED) THAT GAVE A PIXELATED IMAGE. THE PROCEDURE WAS COMPLETED WITHOUT ANY IMPACT TO THE PATIENT. THE PATIENT IS REPORTED TO BE DOING FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20417695 ↗
• InjuryOct 10, 2024Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT DURING A THERAPEUTIC LUNG RESECTION PROCEDURE, USING AIRWAY MOBILESCOPE, THERE WAS NO MOVING IMAGE ON THE SCREEN AND BAD QUALITY IMAGE WAS PRODUCED. NO ERROR MESSAGE WAS PRODUCED. THE PROCEDURE WAS REPORTED TO BE EXTENDED FOR 1 HOUR WHILE THE PATIENT WAS SEDATED, AND THE PROCEDURE TRIED ON A BACKUP OLYMPUS SCOPE WITH A (DIFFERENT MODEL WAS USED) THAT GAVE A PIXELATED IMAGE. THE PROCEDURE WAS COMPLETED WITHOUT ANY IMPACT TO THE PATIENT. THE PATIENT IS REPORTED TO BE DOING FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20417693 ↗
• MalfunctionOct 7, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED DURING DEVICE EVALUATION THAT THE COATING OF THE CONNECTING TUBE ON THE AIRWAY MOBILESCOPE WAS PEELED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20384650 ↗
• MalfunctionSep 26, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED DURING DEVICE EVALUATION THAT THE COATING ON THE INSERTION TUBE OF THE AIRWAY MOBILESCOPE WAS PEELING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20311461 ↗
• MalfunctionSep 18, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE FLEX VIDEO SCOPE IMAGE GUIDE HOSE COATING HAD PEELED OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20245580 ↗
• MalfunctionJul 22, 2024Peeled/Delaminated; Peeled/Delaminated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19793077 ↗
• MalfunctionJun 11, 2024Peeled/Delaminated; Peeled/Delaminated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19510843 ↗
• MalfunctionMay 21, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE AIRWAY MOBILESCOPE HAD A CONNECTING TUBE THAT HAD COATING PEELING (1MM2 OR MORE). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT. ADDITIONAL DETAILS RELATING TO THE PATIENT AND THE EVENT HAVE BEEN REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19367328 ↗
• MalfunctionApr 12, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE AIRWAY MOBILESCOPE EXHIBITED PEELING OFF THE COATING ON THE INSERTION SECTION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19097891 ↗
• MalfunctionFeb 15, 2024Peeled/Delaminated; Peeled/Delaminated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18716651 ↗
• MalfunctionFeb 14, 2024Peeled/Delaminated; Peeled/Delaminated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18705783 ↗
• MalfunctionNov 30, 2023Peeled/Delaminated; Peeled/Delaminated

  OLYMPUS WAS INFORMED THAT THE AIRWAY MOBILESCOPE HAD AN AIR/WATER LEAKAGE. THERE WAS NO REPORT OF PATIENT HARM. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, IT WAS FOUND CONNECTING TUBE HAD COATING 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 18238136 ↗
• MalfunctionJul 31, 2023Peeled/Delaminated; Peeled/Delaminated

  A CUSTOMER REPORTED TO OLYMPUS, THE AIRWAY MOBILESCOPE EXPERIENCED A LEAKAGE. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS IDENTIFIED: THE IMAGE GUIDE SERPENTINE COAT WAS PEELING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17428620 ↗
• MalfunctionJun 27, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE EVENT (AIRWAY MOBILESCOPE HAD INSERTION PART COATING PEELING) WAS FOUND DURING REPROCESSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17213642 ↗
• MalfunctionMar 23, 2023Device Reprocessing Problem; Peeled/Delaminated; Device Reprocessing Problem; Peeled/Delaminated

  FURTHER FOLLOW-UP WITH THE CUSTOMER CONFIRMED THAT THE CLEANING BRUSH WAS NOT INSERTED ON A DAILY BASIS DURING MANUAL CLEANING CAUSING INSUFFICIENT REPROCESSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16596864 ↗
• MalfunctionFeb 7, 2023Loose or Intermittent Connection; Loose or Intermittent Connection

  THE OLYMPUS ADMINISTRATOR REPORTED (ON BEHALF OF THE CUSTOMER) THAT THE BIOPSY VALVE COULD NOT BE ATTACHED TO THE AIRWAY MOBILESCOPE. THE ISSUE WAS FOUND DURING PREPARATION FOR USE, AND THERE WAS NO PROCEDURAL IMPACT OR PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16312064 ↗
• MalfunctionNov 11, 2022Peeled/Delaminated; Peeled/Delaminated

  THE COMPANY REPRESENTATIVE ON BEHALF OF THE CUSTOMER REPORTED, THE BENDING SECTION COVER OF THE AIRWAY MOBILESCOPE HAD PINHOLES. THE DEVICE WAS RETURNED AND AN EVALUATION REVEALED, THE COATING OF IMAGE GUIDE (IG) COIL WAS PEELING OFF (ONE MILLIMETER SQUARE OR MORE). THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION. THERE WERE NO REPORTS OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15781371 ↗
• MalfunctionOct 20, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS IS AN OLYMPUS LOANER DEVICE. DURING MAINTENANCE INSPECTION OF THE DEVICE, IT WAS OBSERVED THAT THE METAL RECEIVER OF THE FORCEPS MOUTHPIECE WAS DETACHED. THERE IS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15638960 ↗
• MalfunctionOct 20, 2022Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS, THE IMAGE FROM THE VIDEO SCOPE DISAPPEARED AT AN ANGLE AFTER A DIAGNOSTIC PROCEDURE (OBSERVATION). THE DEVICE WAS RETURNED, AND AN INSPECTION REVEALED, THE COATING OF THE IMAGE GUIDE (IG) COIL WAS PEELING OFF (ONE MILLIMETER SQUARE OR MORE). THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION. THERE WERE NO REPORTS OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15638236 ↗
• MalfunctionOct 11, 2022Peeled/Delaminated; Peeled/Delaminated

  A USER FACILITY SUBMITTED A REPAIR REQUEST TO THE OLYMPUS SERVICE CENTER, FOR AN AIRWAY MOBILESCOPE, INSERTION TUBE COATING PEELING OFF. UPON INSPECTION AND TESTING OF THE CUSTOMER RETURNED DEVICE, INSERTION GUIDE TUBE COATING WAS FOUND PEELING (1-2 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 15581992 ↗
• MalfunctionOct 7, 2022Device Reprocessing Problem; Device Reprocessing Problem

  THE OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) BECAME AWARE DURING AN IN-SERVICE APPOINTMENT AT THE USER FACILITY, THAT THE CUSTOMER DID NOT LEAK TEST THEIR SCOPES, DID NOT DO THE INITIAL SOAK OF THE SCOPE IN DETERGENT SOLUTION, DID NOT USE THE CORRECT BRUSHES TO BRUSH THE CHANNELS, USED A PISTOL TO FLUSH THE CHANNELS, AND DID NOT USE A FLUSHING PUMP OR THE SUCTION CLEANING ADAPTER TUBING FOR DETERGENT, WATER OR AIR. ALSO, THE CUSTOMER DID NOT WIPE THE SCOPE DOWN AND LET IT SOAK IN DETERGENT SOLUTION AFTER SUCTIONING DETERGENT THROUGH THE CHANNELS. THERE HAVE BEEN NO REPORTS OF PATIENT INJURY OR INFECTION DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15565144 ↗