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

Model Number FS-5U-1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/20/2017

Event Type  malfunction  

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp.(omsc) because the subject device was already discarded.The exact cause has been under investigation.A supplemental report will be submitted, if additional and significant information becomes available at a later time.

Event Description

During a colorectal polypectomy, the user tried to cut the loop with the subject device.At the time, the subject device could not be withdrawn from the patient, because the loop was caught in the cutter of the subject device.Therefore the user severed the insertion portion of the subject device and withdrew the endoscope.After that, he inserted the endoscope into the patient again, removed the polyp with the high frequency snare, and completed the intended procedure.Also, he cut the loop with the similar device and retrieved the distal side of the insertion portion of the subject device.No patient injury was reported.

Manufacturer Narrative

This is a supplemental report for mfr report # 8010047-2017-00295 to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc) because the subject device was already discarded.The lot no.Was unknown.Therefore, as the result of checking the manufacturing record of one year in the past from june 22, 2012 (the date of the delivery), there was nothing abnormal found.The exact cause could not be conclusively determined.However, based on the similar cases in the past, it is 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.

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: hiroki moriyama ; 2951 ishikawa-cho; hachioji-shi, tokyo-to ; 8142642517
• MDR Report Key: 6405301
• MDR Text Key: 69949244
• Report Number: 8010047-2017-00295
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FS-5U-1
• Was Device Available for Evaluation?: No
• 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?: Device Not Returned to Manufacturer
• 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