MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION SINGLE USE GUIDE SHEATH KIT

Model Number K-201

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/27/2013

Event Type  malfunction  

Event Description

Olympus medical systems corp (omsc) was informed that during ebus, the doctor attempted to undergo five biopsies through a guide sheath, but he abandoned them three times due to high resistance between the guide sheath and a biopsy forceps.After that, he inserted a cytology brush in this kit into the guide sheath.When he withdrew the brush he felt friction but he managed to withdraw the brush.Then, the tube of brush was broken.After he examined no section of the brush in the pt bronchus, he called off the procedure.There was no report of pt injury regarding this report.

Manufacturer Narrative

The guide sheath and the cytology brush were returned to omsc for investigation.There were many bents at multiple sites of the both insertion portion.The tube of the brush was stretched and broke.In addition, the broken sheath of the brush was inside the guide sheath.There was no abnormality in the manufacturing records of the same lot.Omsc assumes that the friction between the guide sheath and the cytology brush increased due to many bents of the guide sheath.The doctor pulled the brush forcibly, thus it was broken.This report is being submitted as a medical device report in an abundance of caution.

• Brand Name: SINGLE USE GUIDE SHEATH KIT
• Type of Device: GUIDE SHEATH KIT
• 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: 3694822
• MDR Text Key: 16592995
• Report Number: 8010047-2014-00012
• Device Sequence Number: 1
• Product Code: EOQ
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/27/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: K-201
• Device Lot Number: 2YK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2014
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1