AIRWAY MOBILESCOPE OLYMPUS MAF-TM2Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 04953170407147), received between Jan 6, 2022 and Dec 2, 2024 — classified as 2 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (13 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2024Difficult to Remove; Difficult to Remove

  NO NEW ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20821047 ↗
• MalfunctionSep 19, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THE MOBILESCOPE HAS LIQUID COMING OUT THROUGH THE DISTAL END. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20256350 ↗
• MalfunctionSep 4, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE AIRWAY MOBILE-SCOPE THE COAT OF THE IMAGE GUIDE SNAKE PIPE IS PEELED OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20140061 ↗
• MalfunctionJul 16, 2024Peeled/Delaminated; Peeled/Delaminated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19752086 ↗
• MalfunctionJun 24, 2024No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE AIRWAY MOBILESCOPE HAD IMAGE ISSUES. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19601924 ↗
• MalfunctionJun 21, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE AIRWAY MOBILESCOPE ACTUATOR, SUCTION CYLINDER HAD A FOREIGN OBJECT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19589557 ↗
• MalfunctionJun 18, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED DURING THE INSPECTION OF THE DEVICE, THE COATING ON THE IMAGE GUIDE SNAKE PIPE HAD PEELED OFF ON THE AIRWAY MOBILESCOPE. THERE WERE NO REPORTED INCIDENTS INVOLVING PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19564159 ↗
• InjuryApr 15, 2024Contamination; Contamination

  ADDITIONAL INFORMATION RECEIVED THAT THE PATIENT'S INFECTION WAS VERIFIED BY BLOOD CULTURES. THE REPROCESSOR WAS NOT CULTURED. ONLY THE SCOPES THAT WERE USED ON THE PATIENT WERE CULTURED, WHICH CAME BACK NEGATIVE FOR CARBAPENEM-RESISTANT ENTEROBACTERALES (CRE). AT THE TIME OF THIS REPORT, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND THERE WERE NO OTHER PATIENTS THAT DEVELOPED CRE AFTER USING THE SCOPE. THE FACILITY WAS NOT SURE IF THE PATIENT CAME INTO THE HOSPITAL WITH CRE OR IS HE DEVELOPED IT DURING THE HOSPITAL STAY.

  Patient problems: Drug Resistant Bacterial Infection

  MAUDE report 19105718 ↗
• InjuryApr 15, 2024Contamination; Contamination

  ADDITIONAL INFORMATION RECEIVED. THAT THE PATIENT'S INFECTION WAS VERIFIED, BY BLOOD CULTURES. THE REPROCESSOR WAS NOT CULTURED. ONLY THE SCOPES, THAT WERE USED ON THE PATIENT WERE CULTURED. WHICH CAME BACK NEGATIVE FOR CARBAPENEM-RESISTANT ENTEROBACTERIAL (CRE). AT THE TIME OF THIS REPORT, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND THERE WERE NO OTHER PATIENTS, THAT DEVELOPED CRE AFTER USING THE SCOPE. THE FACILITY WAS NOT SURE IF THE PATIENT CAME INTO THE HOSPITAL WITH CRE OR IS HE DEVELOPED IT, DURING THE HOSPITAL STAY.

  Patient problems: Drug Resistant Bacterial Infection

  MAUDE report 19105622 ↗
• MalfunctionApr 15, 2024Peeled/Delaminated; Peeled/Delaminated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19104941 ↗
• MalfunctionApr 10, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE AIRWAY MOBILESCOPE EXHIBITED INSERTION SITE, FLEXIBLE TUBE, COATING PEELING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19080676 ↗
• MalfunctionMar 18, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE ADHESIVE OF THE BENDING SECTION COVER HAD SEPARATED, THE BIOPSY CHANNEL WAS BLOCKED AND THE INSERTION TUBE WAS DAMAGED ON THE AIRWAY MOBILESCOPE. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18920762 ↗
• MalfunctionFeb 27, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE AIRWAY MOBILESCOPE EXHIBITED THAT THE COAT OF THE IMAGE GUIDE INSERTION SECTION PIPE WAS PEELED OFF (1MM2 OR MORE). THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18785948 ↗
• MalfunctionFeb 21, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE AIRWAY MOBILESCOPE EXHIBITED THE CONNECTING TUBE HAD COATING PEELING (1MILLIMETER TO 2 OR MORE). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18753950 ↗
• MalfunctionFeb 7, 2024Peeled/Delaminated; Peeled/Delaminated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18660759 ↗
• MalfunctionDec 1, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED THE AIRWAY MOBILESCOPE HAD A DAMAGED OPENING. THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. EXAMINATION SHOWED THE INSERTION SECTION'S COATING WAS PEELING; THE PEELING AREA MEASURED 1 MM2 OR MORE. 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 18248514 ↗
• MalfunctionSep 20, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE AIRWAY MOBILESCOPE HAD A CRUSHED INSERTION PART. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE DEVICE WAS RETURNED TO OLYMPUS FOR A DEVICE EVALUATION AND FOUND RESIDUAL LIQUID OR FOREIGN MATERIAL CAME OUT OF THE CHANNEL TUBE. 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 17786378 ↗
• MalfunctionSep 7, 2023Microbial Contamination of Device; Microbial Contamination of Device

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING REPROCESSING, THE AIRWAY MOBILESCOPE HAD A POSITIVE CULTURE TEST. ALL CHANNELS WERE SAMPLED. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17703348 ↗
• MalfunctionAug 30, 2023Contamination; Peeled/Delaminated; Contamination; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE AIRWAY MOBILESCOPE POWER COULD NOT BE TURNED ON. THERE IS NO REPORT OF PATIENT OR USER HARM ASSOCIATED WITH THE EVENT. DURING INSPECTION AND TESTING OF THE RETURNED DEVICE, IT WAS DISCOVERED THAT THE COATING ON THE CONNECTING TUBE WAS PEELING. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION WHICH WAS IDENTIFIED DURING THE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17654714 ↗
• MalfunctionAug 30, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED THE AIRWAY MOBILESCOPE WAS REPROCESSED WITH AN OER-6 ENDOSCOPE REPROCESSOR THAT COULD NOT DRAIN WATER SUFFICIENTLY WHEN REPLACING THE WATER FILTER. THE WATER FILTER WAS NOT CHANGED EVERY MONTH AND IT WAS OPERATED FOR ABOUT HALF A YEAR. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM. THIS REPORT IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIERS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17649036 ↗
• MalfunctionAug 30, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED THE AIRWAY MOBILESCOPE WAS REPROCESSED WITH AN OER-6 ENDOSCOPE REPROCESSOR THAT COULD NOT DRAIN WATER SUFFICIENTLY WHEN REPLACING THE WATER FILTER. THE WATER FILTER WAS NOT CHANGED EVERY MONTH AND IT WAS OPERATED FOR ABOUT HALF A YEAR. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM. THIS REPORT IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIERS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17649016 ↗
• MalfunctionApr 24, 2023Peeled/Delaminated; Peeled/Delaminated

  THE OLYMPUS REPRESENTATIVE REPORTED (ON BEHALF OF THE CUSTOMER), THAT THE COATING ON THE AIRWAY MOBILESCOPE INSERTION SECTION WAS PEELING OFF. THE COATING DETACHMENT WAS NOTICED DURING THE ENDOTRACHEAL CHECK. THE INTENDED TRACHEAL INTUBATION FOR ANESTHESIA, DURING THE LARYNGOSCOPIC MALIGNANT LARYNGEAL TUMORECTOMY PROCEDURE, WAS COMPLETED BY CHECKING THE INSIDE OF THE TRACHEA WITH A FIBER. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT. DURING THE EVALUATION OF THE DEVICE, IT WAS NOTED, THAT THE IMAGE GUIDE SNAKE TUBE COATING WAS PEELED. THIS REPORT IS TO CAPTURE THE REPORTABLE MALFUNCTION OF THE IMAGE GUIDE COATING THAT WAS PEELED OFF AND NOTED AT ESTIMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16795454 ↗
• MalfunctionMar 13, 2023Microbial Contamination of Device; Microbial Contamination of Device

  THE CUSTOMER REPORTED TO OLYMPUS, DURING REPROCESSING, THE AIRWAY MOBILESCOPE TESTED POSITIVE FOR RHIZOBIUM RADIOBACTER. A SECOND MICROBIOLOGICAL TEST WAS PERFORMED AND THE RESULTS ARE PENDING. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16534729 ↗
• MalfunctionAug 30, 2022Peeled/Delaminated; Peeled/Delaminated

  THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS. UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, IT WAS OBSERVED THE COATING ON THE INSERTION TUBE WAS PEELING OFF. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION (COATING PEELING OFF). THERE WAS NO PATIENT OR USER INJURY REPORTED. ADDITIONAL DETAILS HAVE BEEN REQUESTED. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15320697 ↗
• MalfunctionJun 3, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE INSERTION TUBE OF THE SUBJECT DEVICE WAS DAMAGED. THERE WAS NO PATIENT OR USER INJURY REPORTED DUE TO THE EVENT. THE DEVICE WAS RETURNED TO AN OLYMPUS SERVICE CENTER FOR EVALUATION. UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, IT WAS OBSERVED THE BENDING SECTION COVER HAD FALLEN OFF FROM THE DISTAL END. THIS REPORT IS BEING SUBMITTED FOR THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION OF THE DEVICE (BENDING SECTION COVER HAD FALLEN OFF). ADDITIONAL DETAILS HAVE BEEN REQUESTED REGARDING THE REPORTED ISSUE. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14595863 ↗