MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OES CHOLEDOCHOFIBERSCOPE

Model Number CHF-CB30S

Device Problem Microbial Contamination of Device (2303)

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

Event Date 08/25/2017

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has not been returned to olympus medical systems corp.For evaluation, but returned to olympus (b)(4).The subject device was sent to an independent laboratory and microbial culture test on the subject device was conducted.The test result was negative for microbes.The exact cause of the event could not be conclusively determined at this moment.If additional and significant information becomes available, this report will be supplemented.

Event Description

Olympus was informed that the user facility conducted microbial culture test on the subject device and the test result was positive.Totally 2 ufc/endoscope of microbes were detected, and then, acinetobacter species and staphylococci coagulase negative were identified with the amount of 1 ufc/endoscope respectively.The user reportedly follows the instruction manual of the subject device and uses paa (peracetic acid).There was no patient infection associated with this event reported.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Olympus medical systems corp.(omsc) reviewed the manufacturing history of the subject device and confirmed no irregularity.Also, it was confirmed that this device was manufactured on october 29th, 2012.

• Brand Name: OES CHOLEDOCHOFIBERSCOPE
• Type of Device: CHOLEDOCHOFIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• Manufacturer Contact: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to ; 426425177
• MDR Report Key: 7040042
• MDR Text Key: 93688287
• Report Number: 8010047-2017-01802
• Device Sequence Number: 1
• Product Code: FBN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK912120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/22/2017

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: CHF-CB30S
• Other Device ID Number: 04042761007573
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/04/2017
• Initial Date FDA Received: 11/17/2017
• Supplement Dates Manufacturer Received: 11/23/2017
• Supplement Dates FDA Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2012
• 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