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

Model Number CYF-VHR

Device Problem Material Fragmentation (1261)

Patient Problem Urinary Tract Infection (2120)

Event Type  Injury  

Event Description

The customer reports a cluster of five patient (urinary tract) infections following cystoscopy procedures using one of three cysto-nephro videoscopes.During the procedures the user observed foreign bodies shedding from the tips of the scopes.Case with patient identifier (b)(6) reports patient 1 of 5 (this report).Case with patient identifier (b)(6) reports patient 2 of 5.Case with patient identifier (b)(6) reports patient 3 of 5.Case with patient identifier (b)(6) reports patient 4 of 5.Case with patient identifier (b)(6) reports patient 5 of 5.Patient one of five: the procedure performed was a cystoscopy.Four days following the procedure, a urinary tract infection was diagnosed via urine culture.The microorganism identified in the patient¿s urine was escherichia coli (e.Coli).The patient was treated with an unspecified antibiotic.The patient¿s current condition is reported as ¿recovered¿.No additional consequences to the patient have been reported.The facility does not document which scope was used in the procedure record, so it is unknown which of the three scopes was used in this procedure.There were no scope cultures performed by the facility.The customer declined to allow an olympus endoscopic support specialist (ess) visit to observe reprocessing procedures and provide education to the staff as indicated.The customer declined request for olympus to culture the scopes as part of the investigation.The customer emphasized; we cannot conclusively say that the scopes caused the infections.We observed an increase of infections at the same time we observed foreign bodies shedding from the tips of scopes.The customer uses a sterrad automatic scope reprocessor (aer) for sterilization.Pre-cleaning is performed immediately post-procedure following the manufacturer¿s recommended steps.

• Brand Name: 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: 13470873
• MDR Text Key: 285215064
• Report Number: 2951238-2022-00312
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170310522
• UDI-Public: 04953170310522
• 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: 01/11/2022,02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-VHR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/11/2022
• Event Location: Hospital
• Date Report to Manufacturer: 01/11/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other