MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPO VISERA CYSTO-NEPHRO VIDEOSCOPE; CYSTO SCOPE

Model Number CYF-VA2

Device Problems Device Reprocessing Problem (1091); Contamination /Decontamination Problem (2895)

Patient Problem Unspecified Infection (1930)

Event Date 03/01/2015

Event Type  Injury  

Event Description

Olympus medical systems corp (omsc) was informed that 3 patients were infected after having undergone cystoscopy procedure.The user facility possessed 3 cyf-va2s and it was unknown which device was used to each patient.First patient: the user facility was informed that turbid urine was observed from an outpatient.The patient was tested positive for pseudomonas aeruginosa.The patient recovered and was discharged after having hospitalized to have tests.Second and 3rd patient: the user facility was informed that turbid urine was observed from 2 outpatients.The patients were tested positive for pseudomonas aeruginosa.The patients are getting outpatient treatment.

Manufacturer Narrative

The subject device was returned to omsc for evaluation.Based upon the evaluation of the subject device by omsc, it was confirmed that there were foreign substances at the opening of the suction cylinder and at the instrument channel port.Base on the findings, inappropriate reprocessing by the user could not be ruled out as a contributory factor of the event.The manufacturing history was reviewed, with no irregularities related to this problem noted.If additional information becomes available at a later time, this report will be supplemented.Please cross reference the associated complaint files: mfr report#: 8010047-2015-00344 and 8010047-2015-00346.

• Brand Name: VISERA CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: CYSTO SCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPO; 2951 ishikawa-cho; hachioji-shi, tokyo 192- 8507; JA 192-8507
• Manufacturer Contact: susumu nishina ; 2951 ishikawa-cho; hachioji-shi,tokyo 192-8-507 ; JA 192-8507 ; 26425177
• MDR Report Key: 4781870
• MDR Text Key: 21183193
• Report Number: 8010047-2015-00345
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-VA2
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/28/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization