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

Model Number CYF-VHR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 04/22/2021

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.It is reported there is another device is possibly involved (cyf-vh) but we are not clear about the connection at this time.Additional information has been requested to clarify.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.Cross-referenced importer's report number 2951238-2021-00383.

Event Description

It is reported by a (b)(6) physician, a patient experienced a urinary tract infection with the microorganisms pseudomonas aeruginosa (pseudomonas aer.), and enterococcus faecalis (e.Faecalis) 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).

Manufacturer Narrative

This report is being updated to provided additional information and corrected information.

Event Description

Additional information provided by the reporting physician: 5 days after a cystoscopy procedure using this device, pseudomonas aeruginosa and enterococcus faecium were identified in the patient's urine.The patient's current condition is unknown.

Manufacturer Narrative

This report is being updated to provide investigation findings.New information is reported in d8, h6, and h10.The device history record (dhr) for the complaint device could not be reviewed since the serial number was not provided.Olympus does not ship any device that does not meet all design and safety specifications.Conclusion: the definitive root cause could not be identified.Evaluation: pseudomonas aer, e faecalis was detected in the patient by urine culture examination after the case using the suspect device.A review of the facilities reprocessing procedures revealed that the scope channel was not disinfected.The device was not returned to olympus; therefore, a culture test and physical device evaluation could not be conducted.Although olympus received reports of infections in four patients related to the (same) device, the four patients were not infected with the same bacteria.It is unknown whether the patient was a carrier of pseudomonas aer, e faecalis before the case, and it is not possible to determine whether the patient was infected through the device or was a carrier in the first place.In addition, since the sampling and culture test of the scope could not be performed, the relationship between the device and the infection cannot be determined.Since the patients are not infected with the same bacteria, it is unlikely that cross-infection via the scope has occurred.Since the channels were not properly disinfected, it cannot be ruled out that the bacteria remaining in the scope after reprocessing exposed the patient in the next case.The instruction manual for the model states that "injecting disinfectant solution into all channels to disinfect" and "rinsing the channels" during the reprocess.Since it is considered that the occurrence of this event can be prevented by observing this, it is presumed that this event is caused by the user.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12356147
• MDR Text Key: 268075306
• Report Number: 8010047-2021-10637
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170411199
• UDI-Public: 04953170411199
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/23/2022

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-VHR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 87 YR
• Patient Sex: Female