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

Model Number CYF-4A

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

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Manufacturer Narrative

The device was returned to olympus for investigation.The biopsy channel was examined with a rigid telescope and evidence of white residue build-up was found at the distal end of the device and black molykote inside of the biopsy channel.The device failed the leak test, as a leak was noted in the biopsy channel at the bending section area due to cut/torn channel wall.Molykote was found seeping out through the leaking biopsy channel.In addition, the image was foggy and obstructed due to the fluid found inside of the eyepiece, scope body, grip unit, light guide lenses and bending section mesh.The eyepiece was disassembled and excessive broken image guide fibers were found.The damaged device appears to have been attributed to improper maintenance, which may have caused or contributed to this reported event.The device has been serviced.An olympus sales representative had visited the subject user facility immediately following the reported event and conducted in-service training for the hospital staff on how to properly clean and handle the device.In addition, an olympus endoscopy support specialist (ess) visited the facility to perform additional in-depth assessment of the user facilities reprocessing methods and to conduct additional in-service training for the hospital staff.The ess observed the facility was not performing leak testing and was not following reprocessing steps.

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 patients involved in this event.The user facility reported that within a two-week time period, five patients underwent a diagnostic cystoscopy and subsequently developed a fever approximately one week later.Three out of five patients returned to the user facility for treatment following the cystoscopy procedure and microbial cultures were performed.These three patients were said to have tested positive for escherichia coli.Antibiotics were given to three patients to treat a bladder infection; however, only one responded to the initial antibiotic therapy, and two patients were hospitalized for further antibiotic treatment.The user facility reportedly had no detailed information on the other two patients that elected to visit another hospital for treatment.All patients have been released from the hospital and are currently doing well.Please cross reference mfr.Report numbers: 9610773-2008-00001, 2951238-2016-00115, 2951238-2016-00116, and 2951238-2016-00117 to account for the five patients as referenced in the original report.The following report will be supplemented to cross reference the five associated infection complaints: 9610773-2008-00001.

• Brand Name: OES CYSTOFIBERSCOPE
• 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: 5463282
• MDR Text Key: 39126656
• Report Number: 2951238-2016-00114
• 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: Other
• Type of Report: Initial
• Report Date: 02/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CYF-4A
• Device Catalogue Number: CYF-4A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2008
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/16/2008
• 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): Hospitalization; Other; Required Intervention