MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. CYSTONEPHROFIBERSCOPE

Model Number CYF-5A

Device Problem Insufficient Information (3190)

Patient Problem Fever (1858)

Event Date 07/07/2016

Event Type  Injury  

Manufacturer Narrative

This device referenced in this report has not been returned to olympus medical systems corp.(omsc) for evaluation.Omsc reviewed the manufacture history of the subject device and confirmed that there was no irregularity related to the event found.The exact cause of the reported event could not be conclusively determined at this time, however, insufficient reprocessing as the user facility commented could not be ruled out as a contributory factor of the event.If additional information becomes available at a later time, this report will be supplemented.

Event Description

Preoperative inspection of the patient with cystocele was performed using the subject device.Olympus was informed that the patient developed a fever on the following day of the inspection.According to the user facility, other devices other than the subject device were all disposable products.Further, the user facility thought that the subject device caused the fever because it considered the cleaning of the subject device to be insufficient.Since olympus received a request for a study meeting about cleaning and disinfection from the user facility, it was held on july 12, 2016.The user facility continues using the subject device.The patient has been recovered as of july 26, 2016.

• Brand Name: CYSTONEPHROFIBERSCOPE
• Type of Device: CYSTONEPHROFIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: susumu nishina ; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 6425177
• MDR Report Key: 5845998
• MDR Text Key: 51111016
• Report Number: 8010047-2016-01070
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K#: K032092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: CYF-5A
• Device Catalogue Number: CYF-5A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/08/2016
• Initial Date FDA Received: 08/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2014
• 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