MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION BIOPSY VALVE

Model Number MB-358

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Olympus could not evaluate the subject device because it was discarded by the user facility.Olympus service engineers visited the user facility and confirmed the reprocess procedure.As a result, there was no deviation from the instruction manual.It was found that the user facility dried the subject device with a dish drier after wiping the subject device with gauze, which was reprocessed using olympus endoscope reprocessor (oer-2 or oer-3).After the drying, the subject device was kept in a plastic container with a cover.For a cultivation test, the scope channel, in which the biopsy valve was installed, and the distal end were negative.The exact cause of the reported event could not be determined at this time.However, based on similar cases, the following matters could not be ruled out as a contributory factor of the event: it was contaminated at the sampling and cultivation by the user facility, or the bacteria adhered during storage and were detected.

Event Description

Olympus was informed that during a routine inspection by the facility, subject device (mb-358) tested positive for staphylococcus species.The facility also informed that "there were cases during past routine inspection of the facility where a biopsy valve (mb-358) tested positive for anaerobic gram-positive bacteria and a suction valve (mh-443) tested positive for c.Albicans".There were no report of infection associated with this report.This is report one of three.

• Brand Name: BIOPSY VALVE
• Type of Device: BIOPSY VALVE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: susumu nisihina ; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8-057 ; JA 192-8057
• MDR Report Key: 5864102
• MDR Text Key: 51776107
• Report Number: 8010047-2016-01079
• Device Sequence Number: 1
• Product Code: FET
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MB-358
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1