MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE SUCTION VALVE (STERILE)

Model Number	MAJ-209
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was not returned to any of olympus locations.Therefore, olympus could not investigate the subject device.Based upon the information from the user, omsc determined that the user reused the subject device which was forbidden to reuse, consequently the parts of the subject device was damaged and the suction became weak.If additional information becomes available, this report will be supplemented.
Event or Problem Description
Olympus medical systems corp.(omsc) was informed from the user that during the unspecified timing, it was found that the suction was weak.Also omsc was informed from the user that the user had sterilized and reused the subject device.There was no report of patient injury associated with the event.

• Brand Name: SINGLE USE SUCTION VALVE (STERILE)
• Common Device Name: SINGLE USE SUCTION VALVE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 12223468
• Report Number: 8010047-2021-09302
• Device Sequence Number: 14563131
• Product Code: EOQ
• UDI-Device Identifier: 14953170152426
• UDI-Public: 14953170152426
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K201758
• 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 faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/26/2021

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-209
• 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: 06/29/2021
• Initial Report FDA Received Date: 07/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1