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 Problem Urinary Tract Infection (2120)

Event Type  Injury  

Event Description

It is reported by a (b)(6) department of health physician, a patient experienced a urinary tract infection with the microorganism staphylococcus epidermidis (staph epi.) within 15 days of a procedure with a videoscope cyf-v2.It is unknown how the infection was treated.No further consequences to the patient have been reported.The physician further states: we are not attributing the infections to improper reprocessing, only stating that patients had these organisms growing from urine on day 0-15 after the procedure.The incidence of infection does not appear to be outside of the range of ¿normal¿ and there is not a common organism that suggests the scope is persistently contaminated.Additional details have been requested regarding the patient and reported event.At this time, no further information has been provided.This event was reported as one of 4 related events.Case with patient identifier (b)(6) reports patient infection with enterobacter cloacae (e.Cloacae).Case with patient identifier (b)(6) reports patient infection with escherichia coli (e.Coli).Case with patient identifier (b)(6) reports patient infection with staphylococcus epidermidis (staph epi).Case with patient identifier (b)(6) reports patient infection with pseudomonas aeruginosa (pseudomonas aer.), and enterococcus faecalis (e.Faecalis).

• 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: 12356074
• MDR Text Key: 268020310
• Report Number: 2951238-2021-00382
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170411199
• UDI-Public: 04953170411199
• 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: 08/19/2021,08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 08/19/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other