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

Model Number CYF-V2R

Device Problem Contamination /Decontamination Problem (2895)

Patient Problems Fever (1858); Sepsis (2067); 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: 15 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 ¿hospitalized with urosepsis¿.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 (b)(6) 2022.The device was taken out of service (b)(6) 2022.The device was not used between the date of detection and isolation of the device.

Manufacturer Narrative

This event has been reported by the importer on mdr# (b)(4).The device referenced in this report has been returned to olympus for evaluation.The evaluation is not yet finalized.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Manufacturer Narrative

This report is being updated to provide investigation findings.The device history record (dhr) for the complaint device has been reviewed and it is confirmed that the device met all design and quality specification when it was shipped.Chronological information · patient 1, 2, and 3 underwent a procedure using the subject device on (b)(6) 2022.· patient 1 tested positive for urine culture on (b)(6) 2022.As a result of urine culture, e.Coli was positive.· the subject device was isolated on (b)(6) 2022.The subject device had not been used from the day the patient 1 tested positive for urine culture until the day the device was isolated.· patient 2 tested positive for culture test on (b)(6) 2022.As a result of urine culture, e.Coli was positive.· patient 3 tested positive for culture test on (b)(6) 2022.As a result of urine culture, e.Coli was positive.· the facility was re-instructed how to properly clean and store the device on (b)(6) 2022.Physical evaluation of the suspect device showed the following: (1) kinked at distal end of biopsy channel near opening.(2) debris on insertion tube below boot.(3) discoloration on glue around switch button 2 and 3.(4) foreign material buildup on the bending section.(5) foreign material buildup on and surrounding lenses.The instructions for use (ifu) shipped with the device provides the user the following information related to the reported event: describes how to reprocess properly chapter 6 compatible reprocessing methods and chemical agents.Chapter 7 cleaning, disinfection, and sterilization procedures.An olympus endoscopic specialist visited the facility to observe reprocessing processes.The following gaps in the process (as defined in the ifu) were identified: precleaning is performed per patient in reprocessing room and not at bedside.· the customer does not depress the pin inside the connector cap to confirm the leakage is emitting air.· customer utilizes liquid instrument detergent.· the customer took scope back to sink per patient where manual cleaning was performed and rinsed scope with water from faucet.· the customer does not flush alcohol per patient.At end of the day the scope is left coiled on a side table.The definitive cause of the reported events could not be confirmed.Failure to consistently follow the ifu directions for proper cleaning and reprocessing of the scope could have contributed.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14573314
• MDR Text Key: 293363800
• Report Number: 8010047-2022-09257
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170339523
• UDI-Public: 04953170339523
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/24/2022

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-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?: No
• Initial Date Manufacturer Received: 05/12/2022
• Initial Date FDA Received: 06/02/2022
• Supplement Dates Manufacturer Received: 07/27/2022
• Supplement Dates FDA Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other; Hospitalization
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 98 KG