MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VISERA CYSTO-NEPHRO VIDEOSCOPE; FLEXIBLE VIDEO CYSTONEPHROSCOPE

Model Number CYF-V2R

Device Problem Contamination (1120)

Patient Problems Fever (1858); Urinary Tract Infection (2120); Dysuria (2684)

Event Date 04/25/2022

Event Type  Injury  

Event Description

The customer reports after routine cystoscopy procedures using the same visera cysto-nephro videoscope, three patients developed urinary tract infections (the customer originally reported two patients, then later reported a third patient).Case with patient identifier (b)(6) reports the first patient case with patient identifier (b)(6) reports the second patient case with patient identifier (b)(6) reports the third patient for this report: four days after the cystoscopy procedure, the patient developed dysuria and fever.A patient urine sample was cultured and was positive for e.Coli.The patient was treated with antibiotics.The patient¿s current condition is reported as ¿improved¿.The patient had no pertinent health history.The customer reported the endoscope was not sampled and cultured; however later stated that symptoms triggered the device sampling and culturing (no results provided).The customer stated that the device was used on a patient with known infection of the same microorganism.The customer suspects that the device is the cause of the patient infections.It is unknown what other factors may be contributory to this reported event.Environmental factors are not being investigated.No genetic testing about bacteria was detected from the endoscope and the patient.The positive urine culture was detected 29apr2022.The device was taken out of service 02may2022.The device was not used between the date of detection and isolation of the device.

• Brand Name: VISERA CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: FLEXIBLE VIDEO CYSTONEPHROSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 14573191
• MDR Text Key: 293258915
• Report Number: 2951238-2022-00417
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170339523
• UDI-Public: 04953170339523
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/04/2022,06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-V2R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/04/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/04/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 109 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White