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U.S. Department of Health and Human Services

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

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AIZU OLYMPUS CO., LTD. TRACHEAL INTUBATION FIBERSCOPE Back to Search Results
Model Number LF-TP
Device Problem Peeled/Delaminated (1454)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was observed during the device inspection, that the fiberscope exhibited the coating of the image guide hose peeled off 1 to 2mm or more.There were no reports of patient involvement.
 
Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Correction to h6 component code: 3072 - hose does not apply to this event.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 5 years since the subject device was manufactured.Based on the results of the investigation, the peeled coating was likely caused by stress of repeated use, external factors or handling; however, a definitive root cause could not be determined.The event can be detected by following the instructions for use: ¿chapter 3 preparation and inspection 3.2 preparation and inspection of the endoscope".Olympus will continue to monitor field performance for this device.
 
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Brand Name
TRACHEAL INTUBATION FIBERSCOPE
Type of Device
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 Key19201519
MDR Text Key341572822
Report Number9610595-2024-08828
Device Sequence Number1
Product Code EOQ
UDI-Device Identifier04953170136825
UDI-Public04953170136825
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K981543
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 05/28/2024
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
Device Operator Other
Device Model NumberLF-TP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/21/2024
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/23/2024
Initial Date FDA Received04/29/2024
Supplement Dates Manufacturer Received05/20/2024
Supplement Dates FDA Received05/28/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/17/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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