MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. LOOP CUTTER

Model Number FS-5Q-1

Device Problem Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2017

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus medical systems corp.(omsc) for evaluation.There were no any defects on the subject device.As the result of checking the manufacturing record of the same lot, there was nothing abnormal found.The exact cause could not be conclusively determined.However, based on the similar cases in the past, it was known that the loop was caught in between the cutter and the loop hanger due to pulling the slider without positioning the loop vertically to the loop hunger.The instruction manual of the device has already warned as follows; do not try to cut the loop that is not positioned on both edges of the loop hanger as plumb as possible for the blade.It may make cutting the loop impossible, or result in the loop getting caught in the distal end of the instrument, which could make it difficult or impossible to remove from the patient.In this case, use pliers to cut the insertion portion of the instrument where it extends from the biopsy valve of the endoscope.Remove the endoscope from the body, then reinsert the endoscope and cut the loop with a spare loop cutter.

Event Description

During a polypectomy, the doctor tried to cut the loop of hx-400u-30 with the subject device.Then, the doctor could not withdraw the subject device from the endoscope because the loop was caught in between the cutter and the loop hanger of the subject device.After that, the subject device was released when the doctor manipulated the handle of the subject device while the endoscope was kept straight.The intended procedure was completed.No patient injury was reported.

Manufacturer Narrative

This supplemental report is submitting to correct "device product code".

• Brand Name: LOOP CUTTER
• Type of Device: LOOP CUTTER
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• Manufacturer Contact: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 6676237
• MDR Text Key: 79035125
• Report Number: 8010047-2017-00796
• Device Sequence Number: 1
• Product Code: PTS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FS-5Q-1
• Device Lot Number: K2106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 84 YR