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

Model Number	MAJ-855
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During inspection and testing, a white viscous foreign material was found under microscopic analysis.The device history record was unable to be reviewed for this device since it is an accessory.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, component analysis of the white viscous foreign material showed that it was organic silicon.Since silicon is used in various uses such as watertight packing, silicon-based adhesives, or silicon parts, the origin of silicon could not be specified from the analysis.A definitive root cause of the reported issue could not be identified.Olympus will continue to monitor field performance for this device.The reported issue (detaches easily from the endoscope) was not reproduced during testing.At the delivery of the actual item, it was recognized that the luer port was detached from the auxiliary water tube.After assembling the detached luer port and the auxiliary water tube, flushing by using a syringe was performed while attached to a pcf-h290zi endoscope, detachment could not be recognized.
Event or Problem Description
The customer reported the subject device was attached to the endoscope during an unspecified procedure but came off easily.There was no impact to the testing and no effect on the patient due to the event.The subject device was sent to olympus for evaluation.During inspection and testing, foreign material was found inside the device.This report is being submitted for the malfunction found during evaluation (foreign material).

• Brand Name: AUXILIARY WATER TUBE
• Common Device Name: AUXILIARY WATER TUBE
• 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: 15655431
• Report Number: 9610595-2022-03210
• Device Sequence Number: 19446797
• Product Code: FDS
• UDI-Device Identifier: 04953170071508
• UDI-Public: 04953170071508
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K954451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/21/2022

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-855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2022
• 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: 08/01/2022
• Initial Report FDA Received Date: 10/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: PCF-H290ZI: OLYMPUS FLEX VIDEO SCOPE
• Patient Sex: Unknown