MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SUCTION VALVE

Model Number	MH-443
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 was not returned to any of the olympus locations.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
The user informed customer information center (cic) of olympus medical systems corp.(omsc) was informed by telephone from the user that the subject device (the suction valves mh-443), the air/water valves (mh-438), and the biopsy valves (mb-358) used for the endoscopes (gif-1200n/gif-h290/pcf-h290i/pcf-p240ai) at the user facility had been simply soaked in a protein remover, and these reprocessing using the automated endoscope preprocessor (model number unknown) had been performed only once a week, and that the channel cleaning brushes (bw-20t) and the injection tubes (mh-946) had not been reprocessed.The occurrence date of the event is unknown, and there was no report of patient injury associated with this event.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information.The subject device was not returned to any of the olympus locations.Therefore, olympus could not investigate the subject device.Olympus medical systems corp.(omsc) could not review the manufacturing history (dhr) of the subject device because the lot number of the subject device was unknown.The exact cause of the reported phenomenon could not be conclusively determined.However, based upon the reported information, omsc surmised that there was possibility that the reported phenomenon was attributed to inappropriate or insufficient reprocessing by the user.The instruction manual of the subject device states appropriate reprocessing method.If additional information is received, this report will be supplemented.

• Brand Name: SUCTION VALVE
• Common Device Name: SUCTION 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: 13330675
• Report Number: 8010047-2022-01838
• Device Sequence Number: 11972360
• Product Code: FDS
• UDI-Device Identifier: 04953170071256
• UDI-Public: 04953170071256
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2022

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-443
• 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: 02/27/2022
• 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
• Patient Sex: Unknown