MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. FIBERSCOPE "ENF-P4"; RHINO-LARYNGOFIBERSCOPE

Model Number ENF-P4

Device Problem Break (1069)

Patient Problems Abrasion (1689); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

The device was returned to the manufacturer and an evaluation was conducted.A visual inspection was performed on the device with the use of a microscope.It was noted that the bending section cover glue was bumpy and lifted.The device was rough to the touch when tactile force was applied.The bumpy/lifted bending section cover glue was most likely what the patient was experiencing.There was evidence of scratch mark streaks on the bending section cover glue.Additionally, the bending section cover was noted to be stretched causing it to overlap with the distal end tip.The fiber scope was further checked with no evidence of tears.The scope also passed the leak test.The instruction manual warns the user: never operate the bending section, perform suction, insert or withdraw the endoscope¿s insertion tube without viewing the endoscopic image.Patient injury can result.Do not twist or bend the bending section by hands.Equipment damage may result.Do not squeeze the bending section forcefully.The covering of the bending section may stretch or break and cause water leaks.Based on the evaluation the cause of the bumpy/lifted glue was most likely due to mishandling.

Event Description

It was reported that there was a tear at the bottom of the scope which caused the patient pain and scratching of the throat.

• Brand Name: FIBERSCOPE "ENF-P4"
• Type of Device: RHINO-LARYNGOFIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 8865103
• MDR Text Key: 153409748
• Report Number: 8010047-2019-02853
• Device Sequence Number: 1
• Product Code: EOB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENF-P4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/09/2019
• 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
• Patient Outcome(s): Other