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

Model Number FS-5U-1

Device Problem Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/09/2018

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The device was cut off at the insertion part of it.The loop was caught in the distal end other than the loop hanger which holds the loop.After removing the loop from the device, we checked the cutter which cuts the loop and the loop hanger of the device.As a result, there were no abnormalities.The manufacturing history record was reviewed, with no irregularities noted.This type of the event is most likely related to the operator's technique.Based on the past similar cases, it is assumed that the event occurred because the user pulled the operation handle of the device without positioning the loop vertically on 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 colonoscopic polypectomy, the user tried to cut the loop inside the patient using the subject device.The user could not remove the device from the patient, since the loop was caught in the cutter of the device.The user used pliers to cut the insertion part of the device.The user removed the endoscope from the patient while leaving the device inside the patient.The user inserted the endoscope again, cut the loop with another device and removed the device from the patient.The intended procedure was completed.There was no patient injury reported.This is the report regarding the failure of cutting the loop.

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
• MDR Report Key: 7556159
• MDR Text Key: 109624636
• Report Number: 8010047-2018-00967
• Device Sequence Number: 1
• Product Code: PTS
• Combination Product (y/n): N
• 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: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FS-5U-1
• Device Lot Number: K6217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2018
• 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