MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEM CORPORATION FLEXIBLE CYSTONEPHROFIBERSCOPE; FLEXIBLE CYSTONEPHROFIBERSCOPE,

Model Number CYF-5

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

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Olympus followed up with the user facility to obtain additional details regarding the report.The user facility reported that the device was not cultured and it was still in circulation.The seven patients were cultured but the user facility did not provide any details.It was reported that before the patients underwent with their procedures, the patients have previously been diagnosed with the e.Coli.The patients were prescribed with antibiotics and some of the patients were admitted and were provided with intravenous therapy.Olympus also followed up with the sales representative to obtain further details regarding the reported complaints.The sales representative reported that the user facility was re-using a non-olympus water irrigation tubing which had been identified by the user facility to be the root cause of the reported complaint.The device referenced in this report was not returned to olympus for evaluation.The exact cause of the reported phenomenon could not be conclusively determined; however, inappropriate reprocessing practice could not be ruled out as a contributory factor to the reported event.An olympus clinical nurse educator has visited this facility and provided in-service training regarding the appropriate reprocessing of the endoscopes.

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.Olympus was informed that seven patients that had been examined with the device and diagnosed with cipro resistant e.Coli.It was reported that some of the patients were hospitalized and provided an iv.A clinical nurse educator visited the facility and found the following reprocessing inconsistencies: the facility was re-using a single-use non-olympus water tube during manual cleaning and not flushing the channels during pre-cleaning.Leak testing was not being performed.Training and in-service were provided to correct the inconsistencies found.Please cross reference mfr numbers: 8010047-2012-00148, 2951238-2016-00119, 2951238-2016-00120, 2951238-2016-00121, 2951238-2016-00122, 2951238-2016-00123 and 2951238-2016-00124 to account for the seven patients as referenced in the original report.The following report will be supplemented to cross-reference six associated infection complaints: 8010047-2012-00148.

• Brand Name: FLEXIBLE CYSTONEPHROFIBERSCOPE
• Type of Device: FLEXIBLE 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: 5467290
• MDR Text Key: 39278010
• Report Number: 2951238-2016-00123
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031347
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• 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?: No
• Device Operator: Health Professional
• Device Model Number: CYF-5
• Device Catalogue Number: CYF-5
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/13/2012
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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