MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. AIRWAY MOBILESCOPE

Model Number	MAF-GM
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to olympus, that the airway mobilescope had a pinhole in the bending section rubber around 3 centimeters from the tip.Inspection and testing of the returned device found that the connecting tube coating was peeling.There were no reports of patient harm associated with this event.This mdr is being submitted to capture the reportable malfunction found during the device evaluation.
Additional Manufacturer Narrative
The device was returned for evaluation and the customers allegation was not confirmed.It was noted that water tightness was lost due a pinhole on the channel tube, a pinhole on the connecting tube and damage on the camera.The adhesive on the bending section rubber had a chip and the connecting tube had a wrinkle.The bending angle in the up direction did not meet standard value due to wear of the angle wire and the angulation lever did not move smoothly due to damage.The control unit, camera section and scope cover were sticky due to water leakage and the control unit was damaged.The up/down plate was sticky and the image guide bundle had significant breakages.The connecting tube had a dent.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely that the following led to the malfunction: it is presumed that the issue occurred due to stress of repeated use, external factors, or handling.However, a root cause could not be identified.This issue is addressed in the instructions for use (ifu): the instruction manual operation manual ¿chapter 3 preparation and inspection, 3.6 inspection of the endoscope¿ describes the following warning. 4.Inspect the boot and the insertion section near the boot for bends, twists, or other irregularities.5.Inspect the external surface of the entire insertion section including the bending section and the distal end for dents, bulges, swelling, scratches, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, protruding objects, or other irregularities.6.Holding the control section with one hand, carefully run your other hand back and forth over the entire length of the insertion section (see figure 3.23).Confirm that no objects or metallic wire protrudes from the insertion section.Also, confirm that the insertion tube is not abnormally rigid.Olympus will continue to monitor the field performance of this device.

• Brand Name: AIRWAY MOBILESCOPE
• Common Device Name: AIRWAY MOBILESCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18058461
• Report Number: 9610595-2023-16399
• Device Sequence Number: 6962409
• Product Code: EOQ
• UDI-Device Identifier: 04953170340369
• UDI-Public: 04953170340369
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K082720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MAF-GM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2023
• Initial Report FDA Received Date: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2010
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown