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
A biopsy valve, maj-1414, lot# 96v, was returned to olympus for evaluation.The valve was inspected under a microscope and revealed uneven edges inside when viewed from the bottom.Additionally, one of the slits was torn open which is consistent with use.The reported complaint of ¿the seal on the biopsy port that came with the ebus needle is not working well¿ could not be confirmed due to the tear on the slit, causing the valve to no longer fit properly to the test scope.The bottom part was measured across, reading about 15mm and attached to our test scope bf-uc180f.Observed that an ebus needle, returned with the valve, could be passed through the biopsy valve without restriction.A device history record (dhr) review for the maj-1414 with lot number 96v, performed by the legal manufacturer, revealed no abnormalities.
Event or Problem Description
Olympus was notified that the biopsy valve was not ''sealed." it was reported the end users experienced 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.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.Staff reported that the valve was properly placed on the endoscope.This report is #1 of 19 for exposure related to "biopsy valve not sealed.".
Additional Manufacturer Narrative
This supplemental report is submitted to provide the results of the legal manufacturer¿s investigation.The legal manufacturer performed an investigation.A conclusive root cause was not identified.The legal manufacturer determined the likely cause of the leaking as follows:the rubber of the biopsy valve was damaged or deformed by attaching/detaching the biopsy valve and the syringe during the procedure.The biopsy valve was not placed properly to the endoscope.

• 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: 10657819
• Report Number: 8010047-2020-07499
• Device Sequence Number: 19524853
• 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,Followup
• Report Date (Section B): 11/22/2020

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: 96V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/11/2020
• Supplement Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 10/09/2020
• Supplement Report FDA Received Date: 11/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1