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

Model Number	MAF-TM
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During inspection, the insertion section was found to have an area of coating peeled off that measured at least 1 square millimeter.In addition, the bending section cover had chipped adhesive.The connecting tube had wrinkling and buckling which blocked passage of a forceps.Further, the angle wire was stretched, the channel tube had cracks and the image guide bundle showed breakage and stains.The device history record for the subject device was reviewed and no anomalies were found which could cause or contribute to the reported problem.A definitive root cause could not be determined.However, based on the results of the device evaluation and the available information, an investigation determined that the problem of coating peeled off measuring at least 1 square millimeter, was likely caused by stress of repeated use, external factors, or handling.The following statements are provided in the instructions for use for the subject device: inspect the control section and the camera section for excessive scratching, deformation, loose parts, or other irregularities.Confirm that the instrument channel port does not rotate or turn by attempting to rotate or turn the instrument channel port in a counterclockwise direction as shown in figure 3.21.If the instrument channel port is able to be rotated or turned, do not use the endoscope and return it to olympus for repair.(refer to figure 3.21).Visually inspect the rubber part around the instrument channel port.Figure 3.22 depicts the rubber part in a normal and abnormal condition.Lifting of the rubber part is abnormal.If the rubber part is lifted from the molding part as shown in figure 3.22, (abnormal condition) do not use the endoscope and return it to olympus for repair.(refer to figure 3.22) inspect the boot and the insertion section near the boot for bends, twists, or other irregularities.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.
Event or Problem Description
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.

• 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: 16792875
• Report Number: 9610595-2023-06569
• Device Sequence Number: 5733729
• Product Code: EOQ
• UDI-Device Identifier: 04953170288630
• UDI-Public: 04953170288630
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/23/2023

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-TM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2023
• Initial Report FDA Received Date: 04/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2012
• 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