MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEM CORPORATION OLYMPUS EVIS EXERA III VIDEO SYSTEM; ENDOSCOPIC VIDEO IMAGING SYSTEM

Model Number PCF-H190L

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2014

Event Type  Other  

Event Description

Olympus was informed that five colonoscopes tested positive for klebsiella, citrobacter, pseudomonas, stenotrophomonas, e.Coli, enterococcus and other non-specified gram negative bacteria.The user facility cultured the device as part of their microbiological surveillance testing.The device was reprocessed in a non-olympus automatic endoscope reprocessor prior to conducting the test.There was no pt infection associated with this report.

Manufacturer Narrative

The device was sterilized at the user facility prior to being returned to olympus for evaluation.The biopsy chanel and the suction channel were checked with a baroscope and scrape marks were found in the biopsy channel.In addition, there was fluid invasion in the scope connector and light guide prong.The device was serviced and returned to the user facility.The exact cause of the user's report could not be conclusively determined.This reported will be supplemented if additional and relevant info becomes available at later time.An olympus endoscopy support specialist (ess) was dispatched to the user facility to observe the user facility's reprocessing practices.No reprocessing deviations were noted.Please cross-reference the following reports for the other four colonoscopes: 2951238-2014-00034, 2951238-2014-00035, 2951238-2014-00037, and 2951238-2014-00038.

• Brand Name: OLYMPUS EVIS EXERA III VIDEO SYSTEM
• Type of Device: ENDOSCOPIC VIDEO IMAGING SYSTEM
• 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 ave.; san jose, CA 95131 ; 4848965688
• MDR Report Key: 3652377
• MDR Text Key: 4199153
• Report Number: 2951238-2014-00036
• Device Sequence Number: 1
• Product Code: FDF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/13/2014

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: PCF-H190L
• Device Catalogue Number: PCF-H190L
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/16/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2014
• Initial Date FDA Received: 01/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: REPROCESSOR) S/N # UNK; MEDIVATORS DSD EDGE (AUTOMATIC ENDOSCOPE