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

Model Number	MAJ-1555
Date of Event	05/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.The exact cause of the reported incident could not be conclusively determined at this time.The instruction manual warns users "inspect the valve¿s slit and/or hole for damage.Otherwise, pieces of it could fall off.Inspect the biopsy valve for cracks or other damage.".
Event or Problem Description
Olympus was informed that during an unspecified diagnostic procedure, the inner portion of the biopsy valve broke off and fell inside the patient.The surgeon made several unsuccessfully attempts to retrieve the device fragment.The user facility reported that prior to the breakage an endoscopic suturing instrument was passed through the biopsy valve.It was reported that the surgeon expects the patient to excrete the valve naturally.It is unknown if the intended procedure was completed.There was no patient injury reported.Additionally, the user facility reported it was unknown if the valve was inspected prior to use.
Additional Manufacturer Narrative
This supplemental report is being submitted to make a correction on the procode from knw to fds.

• 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
• MDR Report Key: 6642190
• Report Number: 2951238-2017-00409
• Device Sequence Number: 11142298
• Product Code: FDS
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: PK051645
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2019

1 Device 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-1555
• Device Catalogue Number: MAJ-1555
• Device Lot Number: UNKNOWN
• Other Device ID Number: 14953170247573
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/25/2017
• Supplement Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 06/14/2017
• Supplement Report FDA Received Date: 03/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No