MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION OLYMPUS RHINO-LARYNGOFIBERSCOPE

Model Number ENF-P4

Device Problem Material Deformation (2976)

Patient Problem Blood Loss (2597)

Event Date 04/01/2014

Event Type  Other  

Event Description

Olympus medical systems corp.(omsc) was informed that during nasal endoscopy, the doctor felt that it was difficult to withdraw the subject device from the pt, but the doctor removed it with strong force and consequently, the pt had a slight bloody nose temporarily.After removing it from the pt, the doctor found that a metal part was exposed due to a split on the insertion tube.

Manufacturer Narrative

Based on the eval of the subject device by omsc, it was confirmed that the insertion tube was split and there were scratches and indentation marks near the split part.Based on the above result, it is considered that since the user continued to use the device while there were scratches and indentation in the insertion tube, the scratches and indentation grew bigger and it finally tore the insertion tube.It is possible that the scratches and indentation were caused by withdrawing the insertion tube forcibly or hitting the insertion tube with a hard object.The instruction manual of enf-p4 mentions warning and caution for possible mishandling mentioned above.Based on the findings, inappropriate handling by the user could not be ruled out as a contributory factor of the event.This report is being submitted as a medical device report in an abundance of caution.

• Brand Name: OLYMPUS RHINO-LARYNGOFIBERSCOPE
• Type of Device: RHINO-LARYNGOFIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION; 2951 ishikawa-cho; hachioji-shi; tokyo 192- 8507; JA 192-8507
• Manufacturer Contact: hiroki moriyama ; 2951 ishikawa-cho; hachioji-shi; tokyo 192-8-507 ; JA 192-8507 ; 26425177
• MDR Report Key: 3784201
• MDR Text Key: 4440114
• Report Number: 8010047-2014-00181
• Device Sequence Number: 1
• Product Code: CAL
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2014
• 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?: Yes
• Date Returned to Manufacturer: 04/09/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1