MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VISERA CYSTO-NEPHRO VIDEOSCOPE

Model Number CYF-V2

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Skin Discoloration (2074); Swelling (2091)

Event Type  Injury  

Event Description

The service center was informed by the user facility¿s performing doctor that the patient experiences an allergic reaction after undergoing repeat cystoscopy procedures.Due to a pre-existing condition, the patient must undergo a cystoscopy every three months.The patient experiences swelling of the penis and purple discoloration.The patient has no pre-existing allergies.The patient was given topical cream to treat the reaction.The doctor reported that the patient¿s condition last approximately two or three weeks.The doctor reported that only ky lubricant is used.There are no other lubricants, creams, or soaps used during the procedure.This patient is an isolated case, no other patients have been noted with this reaction.The doctor did not know the specific serial number for the referenced scope; therefore, it is unknown if the scope was returned to olympus for evaluation/service and a review of the instrument¿s history could not be performed.The service center did follow up with the user facility to obtain the following additional information: the disinfectant/solution used to reprocess the scope and the patient¿s procedure date; however, this information was not provided.As part of our investigation, the content of this complaint has been escalated to the original equipment manufacturer (oem) for further investigation.

• Brand Name: VISERA CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: CYSTO-NEPHRO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 9507369
• MDR Text Key: 172581254
• Report Number: 2951238-2019-01229
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170287091
• UDI-Public: 04953170287091
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/27/2019,12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CYF-V2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/27/2019
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 11/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention