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 01/11/2019

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The insertion portion was cut off at about 300 mm from the handle.Not the ligature but the loop was caught outside the loop hanger which holds the loop.After removing the loop from the device, the cutter and the loop hanger was inspected but there was no deformation found.The manufacturing record was reviewed and found no irregularities.Based on the past similar cases, 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 hanger.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 of large intestine, the subject device was used.In the procedure, the user tried to cut the ligature with the subject device but the ligature was caught in the cutter part of the device and the user could not cut it.The user cut the insertion portion with a tool and removed the scope since the device could not be withdrew from the patient.The user inserted the scope again and cut the loop using another device.The procedure was completed.No patient injury was reported.This is the report regarding the inability to remove the device.

Manufacturer Narrative

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

• Brand Name: LOOP CUTTER
• Type of Device: LOOP CUTTER
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 8280406
• MDR Text Key: 134189270
• Report Number: 8010047-2019-00966
• Device Sequence Number: 1
• Product Code: PTS
• Combination Product (y/n): N
• PMA/PMN Number: PA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FS-5Q-1
• Device Lot Number: K3523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1