MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. TRACHEAL INTUBATION FIBERSCOPE

Model Number	LF-GP
Medical Device Problem Codes	Peeled/Delaminated (1454); Microbial Contamination of Device (2303); Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during reprocessing, the tracheal intubation fiberscope tested positive for an unexpected contamination.The issue was found during a routine culture of the scope.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
The device was returned to olympus for evaluation and the evaluation found there was coating peeling on the connection tube.The air and water leakage from the channel due to the breakage of the channel tube.The suction volume did not meet the standard due to a broken channel tube.The angle of curvature in the up direction did not meet the standard due to wear of the angle wire.There were specks in the image due to a broken image guide bundle.The connecting tube was wrinkled.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacture's (lm) review of the customer cleaning disinfection and sterilization (cds) processes, results of third-party testing, and the lms final investigation.The lm reviewed the customer provided cds processes where information to judge deviation from ifu was not identified.The user facility provided the following result of the culture test, performed at the third-party labs: <1st test> sampling date: (b)(6) 2023 sampling from: unspecified cfu: 100cfu bacterial identification: gram positive bacilli <2nd test> sampling date: (b)(6) 2023 sampling from: unspecified cfu: 100cfu bacterial identification: gram positive bacilli <3rd test> sampling date: (b)(6) 2023 sampling from: unspecified cfu: 7cfu bacterial identification: gram positive bacilli cfu: 100cfu bacterial identification: gram positive bacilli <4th test> sampling date: (b)(6) 2024 sampling from: unspecified cfu: 2cfu bacterial identification: gram positive bacilli a review of the device history record found no deviations that could have caused or contributed to the reported issue.It was noted during additional follow-up with the user facility that the subject device was not quarantined after microbiological sampling and was used on an unknown number of patients.The reported event was not confirmed as the scope was not microbiologically tested by olympus.The following is included in the device instructions for use (ifu): ¿ifu (reprocessing manual) states ¿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.¿ to warn about inappropriate reprocessing.Operation manual 3.3.2 states: ¿please read before use: warnings and cautions, reprocessing manual 1.1.3, 2.2.1 and 5.5.1 about preventive measures of peeling off coating on the insertion section.¿ olympus will continue to monitor field performance for this device.

• Brand Name: TRACHEAL INTUBATION FIBERSCOPE
• 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: 18591965
• Report Number: 9610595-2024-01747
• Device Sequence Number: 8024729
• Product Code: EOQ
• UDI-Device Identifier: 04953170061998
• UDI-Public: 04953170061998
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K981543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2024
• Supplement Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 01/26/2024
• Supplement Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2021
• 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