MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OES CYSTONEPHROFIBERSCOPE

Model Number CYF-5R

Device Problem Microbial Contamination of Device (2303)

Patient Problems Urinary Tract Infection (2120); Hematuria (2558)

Event Date 06/25/2021

Event Type  Injury  

Event Description

The customer reports two patient infections after a diagnostic cystoscopy using an oes cystonephrofiberscope.This case reports patient one of two : three days after a diagnostic cystoscopy using an oes cystonephrofiberscope (for the indication of microscopic hematuria), the patient developed a urinary tract infection.This was diagnosed with a urinalysis obtained in the emergency room.The patient was treated with cipro 500mg and the symptoms resolved.The scope was not cultured by the facility.Patient two of two is reported in case with patient identifier (b)(6).

Event Description

Correction to g3 of the initial medwatch.The aware date should be 29-jun-2021.

• Brand Name: OES CYSTONEPHROFIBERSCOPE
• Type of Device: CYSTONEPHROFIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 12165532
• MDR Text Key: 261443374
• Report Number: 2951238-2021-00362
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170411182
• UDI-Public: 04953170411182
• 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
• Type of Report: Initial,Followup
• Report Date: 06/29/2021,12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-5R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/29/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/29/2021
• Initial Date Manufacturer Received: 07/13/2021
• Initial Date FDA Received: 07/14/2021
• Supplement Dates Manufacturer Received: 07/13/2021
• Supplement Dates FDA Received: 12/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 80 KG