MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION LIGATING DEVICE; LIGATING DEVICE (POLY LOOP)

Model Number HK-20U-1

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2014

Event Type  malfunction  

Event Description

When the user tried to ligate the polyp of sigmoid colon using the subject device, the loop could not be detached from the hook of this device.The user cut the insertion portion near handle of the device using a plier and withdrew the scope leaving the loop and this device except the handle part in the patient body.After that the user cut the loop with the loop cutter and withdrew this device.There was no report of patient injury regarding this phenomenon.

Manufacturer Narrative

The subject device was returned to olympus for investigation.There were no abnormalities found with the hook itself, but it was heavy to operate the hook.The tube sheath was deformed at the several points and the operation wire was kinked at the several points.As the result of checking the manufacturing record of the same lot, there was nothing abnormal detected.Judging from this investigation and the past similar case, it is considered that since the user attempted to release the loop while the distal end of the coil sheath was not sticking out of the distal end of the tube sheath, the loop was temporarily retracted into the coil sheath, and the loop could not be detached from the hook.The device instruction manual has warned users that there is a possibility that the loop cannot be detached from the device and it also describes what to do if the loop cannot be detached.This report is being submitted as a medical device report in an abundance of caution.

• Brand Name: LIGATING DEVICE
• Type of Device: LIGATING DEVICE (POLY LOOP)
• 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: 4393987
• MDR Text Key: 5436391
• Report Number: 8010047-2014-01155
• Device Sequence Number: 1
• Product Code: FBK
• 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: 12/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HK-20U-1
• Device Lot Number: K4630
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/24/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1