MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. FIBERSCOPE "URF-P5", SET E; URETERO-RENO FIBERSCOPE

Model Number URF-P5

Device Problem Microbial Contamination of Device (2303)

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

Event Date 07/03/2018

Event Type  malfunction  

Manufacturer Narrative

The subject device has not been returned to omsc.The exact cause could not be determined at present.If significant additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that during a routine surveillance culturing test conducted by the facility on (b)(6) 2018, the subject device tested positive for staphylococcus coagulase negative (2cfu/100ml).On (b)(6) 2018, the instrument channel of the subject device also tested positive for staphylococcus hominis (2cfu/endoscope); micrococcus luteus (the number of cfu was not informed).During additional surveillance culturing test by the user facility, the subject device had been manually reprocessed with peracetic acid.There was no report of patient infection associated with the event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Omsc reviewed the manufacture history of the subject device and confirmed no irregularity.The exact cause could not be determined at present.If significant additional information is received, this report will be supplemented.

Manufacturer Narrative

This supplemental report is submitting to correct "device product code".

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device has not been returned to omsc but was returned to olympus (b)(4).The evaluation confirmed following abnormality in the subject device.The subject did not passed air leakage test.The adhesive around the bending section rubber was heavily defective.The distal end unit was damaged.The instrument channel was scratched.The instrument channel port was damaged.The insufficient maintenance at the user facility can not be ruled out as the cause of the reported event.

• Brand Name: FIBERSCOPE "URF-P5", SET E
• Type of Device: URETERO-RENO FIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 7761106
• MDR Text Key: 116915605
• Report Number: 8010047-2018-01574
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• PMA/PMN Number: K912120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/04/2019

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: URF-P5
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/11/2018
• Initial Date FDA Received: 08/08/2018
• Supplement Dates Manufacturer Received: 09/06/2018; 02/13/2019; 03/06/2019
• Supplement Dates FDA Received: 10/04/2018; 02/22/2019; 04/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1