MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. AIR/WATER VALVE

Model Number	MH-438
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device has not been returned to olympus.Therefore, olympus could not investigate the subject device.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.
Event or Problem Description
Olympus medical systems corp.(omsc) was informed from the user that the subject device has been simply soaked in a protein remover and has reprocessed with an automated endoscope "reprocessorone" only once a week.This reprocessing is incorrect and may have been insufficient reprocessed (the user may have used the poor reprocessing subject device for next procedure).In addition, the user requested to olympus to instruct the correct reprocessing way.The occurrence date of the event is unknown.There was no patient injury associated with this report.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information.Since the lot number and the manufacturing date of the subject device are unknown, olympus medical systems corp.(omsc) could not review the manufacturing history (dhr).The exact causes of the reported phenomena could not be conclusively determined.[consideration] -since the subject device was not returned to olympus, the subject device could not be confirmed.It was investigated only with information from the user.-the cause of the reported phenomenon could not be identified.However since it was confirmed that the user reported ¿the subject device has been simply soaked in a protein remover and has reprocessed with an automated endoscope reprocessor only once a week¿, and so it was surmised that the reprocess method was inappropriate or inadequate.If additional information becomes available, this report will be supplemented.

• Brand Name: AIR/WATER VALVE
• Common Device Name: AIR/WATER VALVE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13332946
• Report Number: 8010047-2022-01849
• Device Sequence Number: 1646457
• Product Code: FDS
• UDI-Device Identifier: 04953170071249
• UDI-Public: 04953170071249
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2022

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: MH-438
• 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: 12/27/2021
• Supplement Date Received by Manufacturer: 02/01/2022
• Initial Report FDA Received Date: 01/24/2022
• Supplement Report FDA Received Date: 02/26/2022
• 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