MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. AUXILIARY WATER INLET CAP

Model Number	MAJ-215
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The gastrointestinal videoscope (gif-1100) was returned to an olympus service center for evaluation (manufacturer report number: 9610595-2022-01693).Upon inspection and testing of the returned device, it was observed the auxiliary water inlet cap, maj-215 (subject device), was missing.This report is being submitted for the reportable malfunction of missing auxiliary water inlet cap.There was no harm or user injury reported due to the event.
Additional Manufacturer Narrative
The subject device was not returned to an olympus service center for evaluation.The investigation is ongoing.If additional information becomes available, this report will be supplemented accordingly.
Additional Manufacturer Narrative
H4 device manufacturer date: date of manufacture cannot be identified since the serial number/ lot number was not provided.The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the legal manufacturer's investigation, the root cause of the reported issue could not be identified.The following information is stated in the ifu (instructions for use) operation manual 4.2 insertion: when the auxiliary channel adaptor is not connected to the auxiliary water inlet, attach the auxiliary water inlet cap to the auxiliary water inlet and cover the auxiliary inlet.Otherwise, patient debris or fluids that flow backward may drip from the auxiliary water inlet.Olympus will continue to monitor field performance for this device.

• Brand Name: AUXILIARY WATER INLET CAP
• Common Device Name: AUXILIARY WATER INLET CAP
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15462543
• Report Number: 9610595-2022-02032
• Device Sequence Number: 12452033
• Product Code: FDF
• UDI-Device Identifier: 04953170071713
• UDI-Public: 04953170071713
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K051645
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2022

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-215
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2022
• Supplement Date Received by Manufacturer: 10/18/2022
• Initial Report FDA Received Date: 09/22/2022
• Supplement Report FDA Received Date: 11/10/2022
• 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
• Patient Sex: Unknown