MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION OLYMPUS; OES CYSTONEPHROFIBERSCOPE

Model Number OLYMPUS CYF-5A

Device Problem Insufficient Information (3190)

Patient Problem Irritation (1941)

Event Date 10/27/2016

Event Type  Injury  

Manufacturer Narrative

The subject device was not returned to omsc for evaluation.The manufacturing record of the device was reviewed without irregularity.The facility reported that the patient had developed a rash due to a disinfectant solution used for the endoscope in earlier days.As above, the exact cause of the reported event could not be determined at present.However, the possibility cannot be ruled out that the patient indicated an allergic reaction to a disinfection solution used for the subject device.If significant additional information is received, a supplemental report will follow.

Event Description

Olympus medical system corp.(omsc) was informed that a patient developed redness around the opening of the urethra after having a procedure with the subject device.After the procedure, the patient presented to a dermatologist and got recovered.It is unknown whether facility completed the procedure.The facility thinks that there is no relation between the subject device and the reported event at this time.

• Brand Name: OLYMPUS
• Type of Device: OES CYSTONEPHROFIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION; 2951 ishikawa-cho; hachiouji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: nishina susumu ; 2951 ishikawa-cho,; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 6425177
• MDR Report Key: 6172928
• MDR Text Key: 62323487
• Report Number: 8010047-2016-01531
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K032092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: OLYMPUS CYF-5A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2014
• 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: 65 YR