MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION LOOP CUTTER

Model Number FS-5L-1

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/25/2014

Event Type  malfunction  

Event Description

During an esophageal achalasia's postoperative inspection, the doctor tried to remove a suture thread using the subject device since he judged the suture thread used at the time of the operation could cause passage disorder.The suture thread was closely fixed to the mucous membrane, and the subject device got entangled.The scope was removed from the patient body after cutting of a part of the handle using pliers.After that the scope was inserted again, and the suture thread was cut using the spare (b)(4) device.Bleeding occurred in this occasion.

Manufacturer Narrative

The subject device was returned to olympus for investigation.The investigation confirmed that a suture thread was caught between a loop hanger and cutter and the suture thread could not be detached from the subject device.The purpose of the subject device is cutting a loop.The cause of this event is a user's attempt of cutting a suture thread, which is different from the original purpose.It is supposed that the suture thread was thin and easy to be caught between the loop hanger and cutter.The device instruction manual has indicated that this device can't be removed from a patient body if this device is used for different purposes.This report is being submitted as a medical device report in an abundance of caution.

• Brand Name: LOOP CUTTER
• Type of Device: LOOP CUTTER
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: hiroki moriyama ; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 26425177
• MDR Report Key: 4456762
• MDR Text Key: 5422275
• Report Number: 8010047-2015-00040
• Device Sequence Number: 1
• Product Code: HIN
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 12/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FS-5L-1
• Device Lot Number: K8X23
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/14/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/1998
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1