MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. CONNECTING TUBE; ENDOSCOPE REPROCESSOR ACCESSORIES

Model Number	MAJ-1513
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus that the evis exera iii bronchovideoscope was attempted to be reprocessed on the oer-pro endoscope reprocessor, but the maj-1513/connecting tube would not stay connected to the scope.In speaking with olympus technical assistance support (tac) via phone, the customer noted that when the reprocessing sequence was completed, the connector had come off the scope.The connecting tube could not be connected to the channel connector in the reprocessing basin.The customer only had one bf-p190 scope and one maj-1513 connecting tube.The product will not be returned.There were no reports of patient harm.Related patient identifier: (b)(6).
Additional Manufacturer Narrative
The subject device referenced in this report was not returned for evaluation, therefore the device evaluation could not be completed at this time.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

• Brand Name: CONNECTING TUBE
• Common Device Name: ENDOSCOPE REPROCESSOR ACCESSORIES
• 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: 17720728
• Report Number: 9610595-2023-13091
• Device Sequence Number: 20620098
• Product Code: FEB
• UDI-Device Identifier: 04953170234026
• UDI-Public: 04953170234026
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K103264
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2023

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: MAJ-1513
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: BF-P190 / EVIS EXERA III BRONCHOVIDEOSCOPE; OER-PRO ENDOSCOPE REPROCESSOR
• Patient Sex: Unknown