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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. TRACHEAL INTUBATION FIBERSCOPE

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OLYMPUS MEDICAL SYSTEMS CORP. TRACHEAL INTUBATION FIBERSCOPE Back to Search Results
Model Number LF-TP
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/31/2018
Event Type  malfunction  
Manufacturer Narrative
The scope was not returned to olympus for evaluation.The cause of the reported event cannot be determined at this time.However, the instruction manual warns users¿ do not squeeze the bending section forcefully.The bending section¿s covering may stretch or break and cause water leaks.Inspect the bending section¿s covering for sagging, swelling, cuts, holes or other irregularities.¿ a review of the instruments history revealed the scope was purchased (b)(6) 2002.The scope was last returned to olympus for service on (b)(6) 2004, and it was has not been returned to olympus since then.
 
Event Description
The user facility informed olympus that during an unspecified procedure, the bending rubber from the scope broke off and fell into the patient.The surgeon was able to retrieve the device fragment.It is unknown if the intended procedure was completed.There was no patient injury reported.
 
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Brand Name
TRACHEAL INTUBATION FIBERSCOPE
Type of Device
TRACHEAL INTUBATION FIBERSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA  192-8507
Manufacturer Contact
connie tubera
2400 ringwood avenue
san jose, CA 95131
408935-512
MDR Report Key7305127
MDR Text Key101576584
Report Number2951238-2018-00135
Device Sequence Number1
Product Code EOQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK981543
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial
Report Date 02/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberLF-TP
Device Catalogue NumberLF-TP
Other Device ID Number04953170136825
Was Device Available for Evaluation? No
Date Manufacturer Received02/02/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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