MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ADAPTOR BIOPSY VALVE; SINGLE USE ADAPTER BIOPSY VALVE

Model Number	MAJ-1414
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was not returned for investigation.Device history records for maj-1414 with lot number 64k were reviewed and there were no abnormalities in the records.The exact cause of the reported event could not be identified.Probable causes of the leak may include the following: ·the rubber of the biopsy valve was damaged or deformed by attaching/detaching the needle and the syringe during the procedure.·the biopsy valve was not placed properly on the endoscope.The reported events occurred at one specific facility; it can be inferred that user handling /technique may have contributed to the event.We will continue to monitor the performance of this device.
Event or Problem Description
Olympus was notified that the biopsy valve was not ''sealed¿ and that they were experiencing leaking which increased with patient coughing.The secretions were expelled from the biopsy cap before and/or after the needle was inserted through the cap.It was reported that patient secretions splashed on the face of caregivers on several occasions.During the procedures, the staff wore safety goggles, n95 masks, gowns and gloves.There was no injury reported.No exposure testing has been performed following the exposures.It was reported that end users properly placed the valve on the endoscope.This report is # 16 of 19 for exposure related to "biopsy valve not sealed.".

• Brand Name: SINGLE USE ADAPTOR BIOPSY VALVE
• Common Device Name: SINGLE USE ADAPTER 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: 10645214
• Report Number: 8010047-2020-07336
• Device Sequence Number: 2748240
• Product Code: PSV
• UDI-Device Identifier: 04953170181009
• UDI-Public: 04953170181009
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K050503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/07/2020

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: Health Professional
• Device Model Number: MAJ-1414
• Device Lot Number: 64K
• 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: 09/11/2020
• Initial Report FDA Received Date: 10/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1