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)
Date of Event	08/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation, and the customer's allegation was not confirmed.During the evaluation it was found that the coating on the insertion section peeled off.Additional evaluation findings were as follows: the insertion tube has buckles, due to wear of angle wire, bending angle in down direction does not meet the standard value, due to breakage of image guide bundle, the image has a stain, and indication on connecting tube has a disappeared area.(1mm2 or more).The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
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.
Additional Manufacturer Narrative
This report is being supplemented to provide information that was inadvertently left out of the initial medwatch and to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device met all specifications at the time of shipment.It has been more than 7 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, a conclusive root cause could not be determined.The device's instruction manual provides the following warnings which may help to detect the issue: ·preparation and inspection_ inspection of the endoscope ¿inspect the external surface of the entire insertion tube including the bending section and the distal end for dents, bulges, swelling, peeling, scratching, holes, sagging, transformation, bends, adhesion of foreign body, dropout of parts, any protruding objects or other irregularities.¿ olympus will continue to monitor field performance for 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17707046
• Report Number: 9610595-2023-12934
• Device Sequence Number: 6600085
• Product Code: EOQ
• UDI-Device Identifier: 04953170288630
• UDI-Public: 04953170288630
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K082720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2023

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: 08/15/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2023
• Supplement Date Received by Manufacturer: 09/13/2023
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CV-260 EVIS LUCERA VIDEO SYSTEM CENTER.; CV-260.
• Patient Sex: Unknown