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

Model Number	MAJ-1555
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report for non-fatal serious injury/device malfunction has been stored under the covid-19 pandemic in accordance with the guidance published by fda, postmarketing adverse event reporting for medical products and dietary supplements during a pandemic.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Omsc could not review the manufacturing history record (dhr) because the lot number was not provided, omsc confirmed with another but the similar device that the reported event.Omsc confirmed that the subject device was opens and close properly without any problems.The exact cause of the reported event could not be conclusively determined.However, there was the possibility that the reported phenomenon might be attributed to the damage of the subject device or the inappropriate user handling.
Event or Problem Description
Olympus medical systems corp.(omsc) was informed from the user that the subject device opened easily during an unspecified procedure.There was no report of patient injury associated with this event.

• Brand Name: SINGLE USE BIOPSY VALVE (STERILE)
• Common Device Name: BIOPSY VALVE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10999771
• Report Number: 8010047-2020-10273
• Device Sequence Number: 17013574
• Product Code: FDS
• UDI-Device Identifier: 14953170247573
• UDI-Public: 14953170247573
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K051645
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/14/2020

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: No Information
• Device Model Number: MAJ-1555
• Device Lot Number: UNKNOWN
• 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: 05/14/2020
• Initial Report FDA Received Date: 12/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1