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

Model Number CYF-5

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Manufacturer Narrative

Olympus followed up with the user facility via telephone and in writing to gather additional information, however, only limited information was provided.The device returned to olympus for service with a report of heavy corrosion on the bending section and distal end.The evaluation confirmed the user report of heavy corrosion.The insertion tube had deep cuts and blisters, and the unit failed insulation testing.The instrument channel was also kinked.The device was serviced.As part of our follow-up into this report, an endoscopy support specialist (ess) visited the facility to assess the reprocessing practices and to provide in-service on how to properly reprocess endoscopes.Based upon the information provided by the ess, the facility was not to be reprocessing the device in accordance with the device instruction manual.The facility was not using enzymatic detergent during manual cleaning and was not performing leak testing.The ess provided training on proper reprocessing steps.The cause of the event could not be determined; however, not following reprocessing steps could likely contribute to the reported event.

Event 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 seven patients involved in this event.The user facility reported seven cases of pseudomonas infections after having undergone a cystoscopy procedure.All of the patients were said to have required antibiotics for treatment, and three of the patients were hospitalized.The status of the patients is not currently known.Please cross reference mfr.Report numbers: 2951238-2016-00168, 2951238-2016-00169, 2951238-2016-00170, 2951238-2016-00171 and 2951238-2016-00172 to account for the six patients as referenced in the original report.The following report will be supplemented to cross reference the six associated infection complaints: 9610773-2010-00027.

• Brand Name: OLYMPUS OES CYSTONEPHROFIBERSCOPE
• Type of Device: CYSTOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEM CORPORATION; 2951 ishikawa-cho,; hachioji-shi; tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: donny shapiro ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355161
• MDR Report Key: 5468274
• MDR Text Key: 39303605
• Report Number: 2951238-2016-00173
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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: 06/30/2010
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2010
• 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
• Patient Outcome(s): Required Intervention