MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO FIBERSCOPE

Model Number URF-P7

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/09/2021

Event Type  malfunction  

Manufacturer Narrative

The device has been returned but the evaluation is not yet completed.As such, a definitive root cause of the reported complaint cannot be determined at this time.Supplemental report(s) will be filed as the information becomes available.Device return date is not available.An independent laboratory performed for olympus a culture test for the device on dec 30, 2021, after the device was reprocessed per the directions of the instructions for use.The results were presence of revivable microorganisms at 30°c/endoscope were 8 cfu/endoscope.Conclusion was that with a number of revivable microorganisms greater than 1 cfu/endoscope, the results obtained correspond to the level of action (higher than target level which is <1 cfu) defined in french regulations of july 4, 2016, for an endoscope subjected to high-level disinfection and rinsed with sterile water.As such, the microbiological quality of the endoscope is not satisfactory for an endoscope which is subjected to high level disinfection and rinsed with sterile water.The sampling results are non-conforming.A second sampling test is being performed.Customer provided information of their reprocessing method.During pre-cleaning, suction and rinsing is performed for the channels.Detergent is not used.During manual cleaning detergent used is salvanios ph 10.Brushing is performed for the suction channel, suction piston, suction access port, and distal and areas around the elevator.Model numbers of the brushes used is medi scrub rovers and nova clean vytil cj-edb-230-d2.Disinfecting used for manual cleaning is amioxyde 1000.The device is stored horizontally in a sterile environment.Maintenance of the device is by olympus.The endoscope is sterilized by hydrogen peroxide and peracitic acid.The sterilization model number is paillasse medionosime.Sterilization is done per procedure.

Event Description

As reported by the customer, after a microbiological routine sampling of this device, carried out as required by (b)(4) regulation, unexpected contamination was detected which was above the acceptable threshold.The test was performed prior to use.The user did not report any contamination or any other deterioration in state of health of any person, to which this medical device could have been a contributory cause.

Manufacturer Narrative

The second independent laboratory testing for the device has been performed for olympus.The device evaluation is also completed.This supplemental report is being submitted to provide this information.Please see the updates in sections.An independent laboratory performed for olympus a second culture test for the device after the device was reprocessed per the directions of the instructions for use.The test results indicate that the culture sampling results for all channels conform to the target levels established by the (b)(6) regulation of (b)(6) 2016 with a number of revivable microorganisms less than 1 cfu/endoscope.The device was inspected and tested.There were no defects or lack of conformity found.The device did not require any repairs.Evaluation is ongoing.Supplemental report(s) will be filed as any information becomes available.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 2 years since the subject device was manufactured.Based on the results of the investigation, the relation between the event and the device could not be confirmed.Though lower than that standard value, growth was confirmed after reprocessing in accordance with the instructions for use (ifu).This information is addressed in the instructions for use (ifu): "reprocessing manual:1.4 precautions: warning: an insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who touch them." olympus will continue to monitor the field performance of this device.

• Brand Name: URETERO-RENO FIBERSCOPE
• Type of Device: URETERO-RENO FIBERSCOPE
• 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: 13206429
• MDR Text Key: 289760588
• Report Number: 8010047-2022-01125
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170403811
• UDI-Public: 04953170403811
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K181451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-P7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2020
• 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