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

Model Number CYF-VHA

Device Problem Device Reprocessing Problem (1091)

Patient Problem Unspecified Infection (1930)

Event Date 04/01/2015

Event Type  Injury  

Event Description

Olympus medical systems corp (omsc) was informed that 2 patients developed cystitis after having undergone cystoscopy procedure.The patients were cured with antibiotics.One of the patients was male in his sixties.The attending physician commented that insufficient reprocessing might have caused the cystitis.There were a total of 5 cystic scopes including 2 loaned devices.It was unk which device was used to each patient.

Manufacturer Narrative

This device referenced in this report has not been returned to olympus for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information, or if a device is received at a later time, this report will be supplemented.The manufacturing history was reviewed, with no irregularities related to this problem noted.Please cross refence the associated complaint files: mfr report#: 8010047-2015-00363, 8010047-2015-00364, 8010047-2015-00387, and 8010047-2015-00389.

• Brand Name: CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: CYSTO SCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP; 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: 4781862
• MDR Text Key: 5801510
• Report Number: 8010047-2015-00388
• 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: 04/22/2015

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?: No
• Device Operator: Health Professional
• Device Model Number: CYF-VHA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization