MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEM CORPORATION OLYMPUS OES CYSTONEPHROFIBERSCOPE; CYSTOSCOPE

Model Number	CYF-5
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Codes	Unspecified Infection (1930); Urinary Tract Infection (2120)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Olympus followed up with the user facility to obtain additional information regarding the report.The user facility reported that the four patients were cultured and the results were positive for the same microorganism.The user facility claimed that the reprocessing areas were cultured with no growth found.As part of our investigation, an olympus endoscopy support specialist was dispatched to assess the facility's reprocessing practices and provide reprocessing training if necessary.The user facility declined the in-service.The device was sent to an independent testing laboratory for microbiological testing.The testing found no growth of pseudomonas aeruginosa.The device was subsequently returned to olympus for evaluation.The evaluation found residue and debris inside of the biopsy channel and in the channel mount unit.The image was dark and blurry due to black residue noted on the objective lens and on the light-guide lens.The image was fine after the black residue was removed.Additionally, black residue buildup was found on the distal end cover and minor residue build up was found on the bending section cover.There were multiple kinks noted on the biopsy channel at multiple locations throughout the insertion tube and at the bending section area.There was a small cut at 11mm from the distal tip which attributed to a leak at the bending cover.The insertion tube was peeling with nicks and scratches.The exact cause of the reported event cannot be determined.The referenced device was previously returned to olympus for service/repair on 06/12/2012 and a new bending section cover was installed.
Event or Problem Description
Oca undertook a retrospective review of its mdr files for the period of january 2005 to april 2015.Based upon this review, we are submitting this mdr to separately account for each of the four patients involved in this event.Olympus was informed that after a cystoscopy procedure, four patients developed pseudomonas uti, and sepsis with the same resistant bacteria and resistance profile.The user facility reported that sterilization process was assessed by an unidentified olympus nurse specialist without any issues observed.Please cross reference mfr.Report numbers: 8010047-2013-00064, 2951238-2016-00136, and 2951238-2016-00137 to account for the four patients as referenced in the original report.The following report will be supplemented to cross reference the three associated complaints: 8010047-2013-00064.

• Brand Name: OLYMPUS OES CYSTONEPHROFIBERSCOPE
• Common Device Name: CYSTOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEM CORPORATION; 2951 ishikawa-cho; hachioji-shi, tokyo, 192-8 507; JA 192-8507
• MDR Report Key: 5477407
• Report Number: 2951238-2016-00135
• Device Sequence Number: 294567
• Product Code: FAJ
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K993041
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/03/2016

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
• Operator of Device: Health Professional
• Device Model Number: CYF-5
• Device Catalogue Number: CYF-5
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2013
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2013
• Initial Report FDA Received Date: 03/03/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention