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 08/24/2021

Event Type  malfunction  

Manufacturer Narrative

The event date is currently unknown.Third party testing results have not yet been received from the customer.The investigation is ongoing; therefore, the root cause of the reported issue/malfunction cannot be determined at this time.However, if additional information becomes available a follow up medical device report will be supplemented accordingly.

Event Description

Olympus (b)(4) was informed by the user facility that after a microbiological routine control on this uretero-reno fiberscope, the user facility detected an unexpected contamination.The user facility did not report any contamination or any other serious deterioration in state of health of any person, to which this medical device could have been a contributory cause.The scope has been returned to the regional repair center.

Manufacturer Narrative

This supplemental report was submitted to provide additional information regarding the device and a correction to the event date (b3).Section e2 & e3 remain unknown.Olympus (ofr) forwarded the scope to an external laboratory for further microbial testing which resulted in no relevant hygiene relevant germs were found.The scope was sterilized and returned to the regional repair center for a physical evaluation.The inspection noted the bending section cover at the distal end was significantly stretched, and or wrinkles together which increases the standard diameter.Additional information regarding the cleaning, disinfection and or sterilization of the device was provided.During bedside pre-cleaning for endoscopes, the user facility uses albyn medical scope clean.Cleaning detergent used is anios clean excel d.The disinfectant used for disinfection is anioxy twin.The biopsy calve, air valve, and suction valves a re manually disinfected.The endoscope is stored in typhoon storage and are serviced by olympus.

Manufacturer Narrative

This supplemental report was submitted to provide the results of the customer's microbiologic test for the concerned endoscope.

Event Description

According to the customer's external laboratory microbiologic test results, the scope tested positive for an unspecified micro-organism (1cfu).

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device was evaluated where no abnormalities were found that could have led to the positive culture.A few defects were noted during the evaluation however, those defects were not considered severe enough to cause a potential adverse event.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been 2 years since the subject device was manufactured.Based on the results of the investigation, it is unlikely the positive culture was caused by the device.Growth of microorganisms were found through culture testing by the user after reprocessing.However, when olympus culture tested after reprocessing in accordance with instructions for use (ifu) before repair, growth of microorganisms could not be confirmed.The following is included in the instructions for use (ifu) related to incorrect reprocessing: "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." additionally, the bending section cover was significantly stretched which was likely caused by user handling.The following is included in the instructions for use (ifu) related to improper handling of the device: "also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, or light guide cable with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations.It could also cause parts of the endoscope to fall off inside the patient." olympus will continue to monitor field performance for 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: 12553890
• MDR Text Key: 274002313
• Report Number: 8010047-2021-12499
• 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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• 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: 09/23/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2019
• 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