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

Model Number HX-400U-30

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/17/2015

Event Type  malfunction  

Event Description

During a gastroscopic polypectomy, the customer attempted to push the slider of the subject device to release the loop after ligating the polyp but the slider couldn't work.The customer forcibly pulled the subject device with the polyp ligated, and removed the polyp physically.After removing the polyp, the procedure was completed using a hemostasis clip as preventive measures.No pt injury was confirmed by the scopic investigation the next day.

Manufacturer Narrative

The subject device was returned to olympus for investigation.It is confirmed that the loop wasn't able to be released since the operation pipe of the subject device broke and the slider wasn't able to work.Ant it is supposed that the operation pipe was kinked, given tension, and broke.The mfg record for the same lot number of the subject device indicated that no abnormalities related to the reported phenomenon.From the above inspection result, it is concluded that the operation pipe was pushed and kinked while the coil sheath was sharply curved, and the operation pipe became bent and broken after the slider was pulled.The instruction manual of the subject device states below: always have the olympus loop cutter ((b)(4)) ready to cut the coil sheath, tube sheath and operation wire in case the loop cannot be detached from the instrument; do not withdraw the instrument or change the angulation of the endoscope before the look is detached from the instrument during a ligation.This report is being submitted as a mdr in an abundance of caution.

• Brand Name: SINGLE USE 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: 4528509
• MDR Text Key: 19803039
• Report Number: 8010047-2015-00096
• Device Sequence Number: 1
• Product Code: FDS
• 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: 01/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HX-400U-30
• Device Lot Number: K4702
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/26/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1