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

Model Number CYF-5

Device Problem Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Date 08/20/2010

Event Type  Injury  

Manufacturer Narrative

The cystoscopes in question were sent to a laboratory for microbiological testing.Following the microbiological testing, the devices were sent to olympus for evaluation.The evaluation results are as follows: cyf-5 with sn# (b)(4): the device was forwarded to a laboratory for microbiological testing.The device tested negative for growth.The device was forwarded to olympus for evaluation following the laboratory microbiological testing.The evaluation found reddish-orange residue inside the device.The evaluation also found that the device failed leak testing at the control body.Cyf-5 with sn# (b)(4): the device was forwarded to a laboratory for microbiological testing.The device tested negative for growth.The device was forwarded to olympus for evaluation following the laboratory microbiological testing.The evaluation found white residue in the instrument channel port and on the distal end of the device.The evaluation also found deep cuts in the insertion tube.Cyf-5 with sn# (b)(4): the device was forwarded to a laboratory for microbiological testing.The device tested negative for growth.The device was forwarded to olympus for evaluation following the laboratory microbiological testing.The evaluation found white residue in the instrument channel port and on the distal end of the device.The evaluation also found a leak at the air valve.Cyf-5 with sn# (b)(4): the device was forwarded to a laboratory for microbiological testing.The device tested negative for growth.The device was forwarded to olympus for evaluation following the laboratory microbiological testing.The evaluation found white residue in the instrument channel port and on the distal end of the device.The evaluation also found 8 broken image fibers and a leak at the eto valve.Based on the device evaluation results, the most likely cause of the reported events is due to improper maintenance of the device.

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 ten patients involved in this event.Olympus was informed that ten patients tested positive for urinary escherichia coli (e.Coli) infections after undergoing diagnostic cystoscopy procedures, with four different cystoscopes.It was not known which of the four devices (sn.(b)(4)) are alleged to be the source of the infections.All patients have reportedly recovered.Please cross reference mfr.Report numbers: 8010047-2010-00184, 8010047-2010-00185, 8010047-2010-00186, 8010047-2010-00190, 2951238-2016-00155, 2951238-2016-00156, 2951238-2016-00157, 2951238-2016-00158, and 2951238-2016-00160 to account for the ten patients as referenced in the original report.The following four reports will be supplemented to cross reference the ten associated infection complaints: 8010047-2010-00184, 8010047-2010-00185, 8010047-2010-00186 and 8010047-2010-00190.

Manufacturer Narrative

This supplemental report is being submitted to correct the event date from (b)(6) 2016 to (b)(6) 2010.

• Brand Name: OLYMPUS OES CYSTONEPHROFIBERSCOPE
• Type of Device: CYSTONEPHROFIBERSCOPE
• 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: 5482030
• MDR Text Key: 39738398
• Report Number: 2951238-2016-00159
• 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,Followup
• Report Date: 06/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2016
• 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: 09/23/2010
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2017
• 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): Other
• Patient Age: 47 YR
• Patient Weight: 71