MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEM CORPORATION EVIS EXERA II DUODENOVIDEOSCOPE

Model Number TJF-160VF

Device Problem Device Contamination With Biological Material (2908)

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

Event Type  Other  

Event Description

Olympus was informed that a duodenovideoscope was cultured positive for an unk organism.In addition, the duodenovideoscope had a broken elevator.Olympus followed up with the rptr to obtain add'l info regarding the event, but with no results.

Manufacturer Narrative

The device is still under eval by olympus.A supplemental report will be submitted when add'l and significant info becomes available later.

• Brand Name: EVIS EXERA II DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEM CORPORATION; 2951 ishikawa-cho, hachioji-shi; tokyo 192- 8507; JA 192-8507
• Manufacturer (Section G): OLYMPUS MEDICAL SYSTEM CORPORATION; 2951 ishikawa-cho, hachioji-shi; tokyo 192- 8507; JA 192-8507
• Manufacturer Contact: laura storms ; 2400 ringwood avenue; san jose, CA 95131 ; 4848965688
• MDR Report Key: 3596360
• MDR Text Key: 4066038
• Report Number: 2951238-2014-00010
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/16/2013

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: TJF-160VF
• Device Catalogue Number: TJF-160VF
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/16/2013
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/16/2013
• Initial Date FDA Received: 01/14/2014
• 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
• Patient Outcome(s): Other