MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. MH-908 BLIND PROBE (D); ULTRASONIC PROBE FOR ESOPHAGUS

Model Number MH-908

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/15/2017

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has not been returned to olympus medical systems corp.For evaluation.The manufacturing record of the subject device was reviewed with no irregularity.The exact cause of the event could not be conclusively determined at this moment.If additional information is available, this report will be supplemented.

Event Description

Olympus was informed that the subject device was culture tested twice on (b)(6) 2017 and the test results were positive for stenotrophomonas maltophilia with the amount of 256 ufc and over 200 ufc respectively.The microorganism was detected from the water channel of the subject device.There was no report of patient infection associated with this report.

• Brand Name: MH-908 BLIND PROBE (D)
• Type of Device: ULTRASONIC PROBE FOR ESOPHAGUS
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 6577654
• MDR Text Key: 75771700
• Report Number: 8010047-2017-00619
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial

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
• Device Operator: Health Professional
• Device Model Number: MH-908
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/21/2017
• Initial Date FDA Received: 05/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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