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 Consequences Or Impact To Patient (2199)

Event Date 08/17/2017

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The evaluation found following failures: although a part of the adhesive of bending rubber on the control section side remained, it was almost peeled off.The adhesive on the distal end side was scratched.The distal end and the control section were damaged.The part of the coating over the ett was peeling off and there were scratches on the ett.Omsc reviewed the manufacture history of the subject device and confirmed no irregularity.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 by interference with an ett.The operation manual of the subject device has already described as follows: if the ett cannot be easily slid into place over the insertion tube of the endoscope, do not use it.If the ett is forced into place, the insertion tube may be damaged or it may be impossible to remove the ett from the endoscope.Never use a damaged ett.Patient injury and/or equipment damage may result.The angulation control lever should not be operated when the bending section is inside of the ett.

Event Description

Olympus was informed that when an anesthesiologist inserted an endotracheal tube (ett), fragments of the bending section of the subject device fell off into the patient.The user facility retrieved the fragments.The procedure was completed using a similar device.The same complaint occurred at the user facility on (b)(6) 2017 (mfr report # 8010047-2017-01242).There was no patient injury associated with this report.

• 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: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 6867887
• MDR Text Key: 86415832
• Report Number: 8010047-2017-01342
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK981543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LF-GP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2017
• 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