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

Model Number URF-P6

Device Problem Microbial Contamination of Device (2303)

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

Event Date 09/08/2021

Event Type  malfunction  

Manufacturer Narrative

The customer hmi (hygiene microbiological investigation) results reported the device tested positive with mold.Below are information on customers cds checklist: life nova clean for pre clean bedside aniosyme x3 the detergent used for cleaning anioxyde 1000 disinfectant used for disinfection autoclave for sterilization investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

As reported, after a microbiological routine control test on the subject medical device as required by (b)(6) regulation, the user detected an unexpected contamination.The issue found during reprocessing.The user then sent the device to the ofr (b)(4) subsidiary for hmi (hygiene microbiological investigation) for further investigation.The user did not report any contamination or any patient injury or patient infection.No user injury reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the device evaluation, legal manufacturer's final investigation and the hygiene microbiological investigation report.After the device was returned to olympus, it was sent out for additional testing.The hygiene microbiological investigation report indicated the channels of the scope were cultured 3 times: first test, all channels: staphylococcus sp., coagulase negative: 14cfu/endoscope.Second test, all channels: staphylococcus sp., coagulase negative: 4cfu/endoscope.Third test, all channels: staphylococcus sp., coagulase negative: 2cfu/endoscope.For all tests, the detected microorganisms were higher than action value.Therefore, a temporally visual inspection was conducted and confirmed the channel mount unit (k-mount unit) of the subject device was worn out.The repair department confirmed the a-rubber glue peeled off, the bending section was damaged, and the channel mount unit (k-mount unit) was worn out.A culture test was performed after the repair where is was found that the level of detected microorganism was lower than the standard value of the local regulation (<1colony forming unit/endoscope).A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 4 years since the subject device was manufactured.Based on the results of the investigation, it is likely that the event occurred by residual microorganism at the worn channel mount unit (k-munt unit).The channel mount unit (k-munt unit) may have been worn out by contact with endo therapy accessories or cleaning brushes though a definitive root cause cannot be identified.This information is addressed in the instructions for use (ifu): "3.8 inspection of the endoscopic system: inspection of the instrument channel: if significant resistance is encountered and insertion becomes very difficult, straighten the bending section as much as possible without losing the endoscopic image.Inserting endotherapy accessories with excessive force may damage the endoscope and/or the endotherapy accessories.Confirm that the tip of the endotherapy accessory is closed or retracted into its sheath and slowly insert the endotherapy accessory into the forceps port of the sealing accessory.Do not open the tip of the endotherapy accessory or extend the tip of the endotherapy accessory from its sheath while inserting it into the channel.The endoscope and/or the endotherapy accessory may be damaged.1.4 precautions: an insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who contact 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: 12637272
• MDR Text Key: 276663780
• Report Number: 8010047-2021-13177
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K172298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-P6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2017
• 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