MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. FIBERSCOPE "LF-GP"; TRACHEAL INTUBATION FIBERSCOPE

Model Number	LF-GP
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned to olympus for evaluation.The cleaning, disinfection, and sterilization (cds) was performed by the customer.The device was dried by filtered compressed air and the dry process of the automated endoscope reprocessor (aer) and stored in a drying cabinet.The customer did not provide the specific steps taken during the cleaning sterilization and disinfection (cds) process.The customer did confirm that there were no deviations or deficiencies concerning reprocessing of the scope.Additionally, the customer confirmed that there were no suspected patient infections due to the facility findings.A supplemental report will be submitted if any additional information is provided by the user facility.
Event or Problem Description
The customer reported to olympus that during routine microbiological testing, the fiberscope tested positive for an unexpected contamination.The user did not report any contamination or any other serious deterioration in state of health of any person, to which the scope could have been a contributory cause.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Despite good faith attempts the user culture results and cleaning disinfection and sterilization (cds) processes were not shared.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation and because the user culture results were not shared, the reported event could not be confirmed and a root cause could not be determined.Instructions for use (ifu) (reprocessing manual) warns on insufficient reprocessing by stating ¿failure to properly clean and high-level disinfect or sterilize endoscopic equipment after each examination can compromise patient safety.To minimize the risk of transmitting diseases from one patient to another, after each examination the endoscope must undergo thorough the manual cleaning followed by high-level disinfection or sterilization.¿ olympus will continue to monitor field performance for this device.

• Brand Name: FIBERSCOPE "LF-GP"
• Common Device Name: TRACHEAL INTUBATION FIBERSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18222714
• Report Number: 9610595-2023-18195
• Device Sequence Number: 5709333
• Product Code: EOQ
• UDI-Device Identifier: 04953170061998
• UDI-Public: 04953170061998
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K981543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: LF-GP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2023
• Supplement Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 11/28/2023
• Supplement Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2005
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown