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

Model Number LF-GP

Device Problems Break (1069); Fracture (1260); Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/03/2017

Event Type  malfunction  

Manufacturer Narrative

The subject device in this report has not yet been returned to olympus medical systems corp.(omsc) for evaluation.Omsc reviewed the manufacture history of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available or if the device is returned at a later time, this report will be supplemented.

Event Description

Olympus was informed that when the user facility inserted an endotracheal tube (ett), fragments of the bending section of the subject device fell off into the airway of the patient.The user facility retrieved the fragments.The patient got a ct scan to ensure all pieces were removed.The user facility completed the procedure without exchanging the subject device.There was no patient injury reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation result.The subject device and the fragment were returned to olympus medical systems corp.(omsc) for evaluation.The evaluation of the subject device by omsc confirmed following.- as reported from the user facility, two parts of resin outside the insertion tube of the subject device were peeled off.Part1: the part of the coating was peeling off.There were tears and cracks on the insertion tube between 65 mm to 90 mm from the distal end.Part2: the part of the coating was peeling off.There were tears and scratches on the insertion tube between 137 mm to 158 mm from the distal end.- the fragment surface fell off into the patient was a shape split in the insertion/removal direction.There was no chemical damage trace on the resin.- the part of the coating over the insertion tube was peeling off.- the part of the index of length disappeared.- there were kinked on the insertion tube.- there were chips on the adhesive of bending rubber.- there were cuts on the rubber of the bending section.The above damages of the subject device could be caused due to physical stress.It is considered that the fragments could fall off due to physical stress applied to the insertion tube of the subject device.The operation manual of the subject device has already described as follows; -visually inspect the surface of the insertion tube for dents, bulges, swelling, peeling or other irregularities.

• 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
• Manufacturer Contact: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to ; 426425177
• MDR Report Key: 6992533
• MDR Text Key: 92045555
• Report Number: 8010047-2017-01620
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK981543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LF-GP
• Other Device ID Number: 04953170061998
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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