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 12/19/2017

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 and it could cut a loop.The manufacturing history record was reviewed, with no irregularities noted.Based on the past similar cases, it is assumed that the event occurred because the doctor pulled 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 an unspecified procedure, the subject device was used.When the user tried to cut the loop with the subject device, the loop was caught in the subject device and the user could not remove it.After that, the user could release the subject device by moving it.No patient injury was reported.No further information 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
• MDR Report Key: 7188693
• MDR Text Key: 97752811
• Report Number: 8010047-2018-00036
• 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: 01/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FS-5U-1
• Device Lot Number: K4210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/25/2017
• 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