MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. AIR/WATER VALVE

Model Number	MAJ-1444
Medical Device Problem Codes	Device Reprocessing Problem (1091); Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter name and address- address:- full name of the facility establishment is (b)(6).The device (maj-1444) was not returned for evaluation.In communication with the facility, it was conveyed that " reprocessing properly implements brushing".The scope in the reported event was returned for evaluation under report patient identifier (b)(6).Supplemental report(s) will be submitted should any relevant new information is available.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Event or Problem Description
It was reported dirt observed coming out from the tip of the scope gf-uct260, string of blood was observed.The use of device was immediately discontinued and was not used on another patient.According to the report, the device was cleaned using an oer-5 (scope reprocessor machine) after its uses on 12/2 and in the morning of 12/6, the reported event occurred.There was no harm reported.No patient harm, no user injury reported as the result of the event.There is no patient infection associated on this reported event.The scope on the event reported was used in combination with maj-1444 device (air/water valve unit).This report is being submitted for the maj-1444 device (air/water valve unit)- report with patient identifier (b)(6).This event includes two reports : report with patient identifier (b)(6) (maj-1444).Report with patient identifier (b)(6) ( scope gf-uct260, sn (b)(4)).This report is for report with patient identifier (b)(6) (maj-1444).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial 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 investigation, the root cause of the foreign material was unable to be identified.Olympus will continue to monitor field performance for this device.

• Brand Name: AIR/WATER VALVE
• Common Device Name: AIR/WATER VALVE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16100704
• Report Number: 3002808148-2023-00097
• Device Sequence Number: 6093215
• Product Code: ODG
• UDI-Device Identifier: 04953170209680
• UDI-Public: 04953170209680
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2023

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-1444
• Device Lot Number: N/A
• 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: 12/08/2022
• Supplement Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 01/05/2023
• Supplement Report FDA Received Date: 02/22/2023
• 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: GF-UCT260, SN (B)(4)OER-5
• Patient Sex: Unknown