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 10/17/2018

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus for evaluation.The string was caught in the scissors.The scissor's blade was partially missing.The manufacturing record was reviewed and found no irregularities.This type of the event is most likely related to the operator's technique.Based on the past similar cases, it was known that this event occurred since an object other than the surplus of olympus loop was cut.The instruction manual of the device has already warned as follows: do not use the instrument to cut any objects other than the surplus of olympus loop (e.G., maj-254, maj-340).If anything other than the surplus of the loop is cut, the blades may be damaged and unable to perform properly, the cut object may be caught in the tip of the instrument, and it may become difficult to safety remove the instrument from the body.Such objects other than the surplus of loop may include stent wire, sewing threads, and loop stoppers.

Event Description

During an esd, the subject device was used.The user tried to cut the string attached the clip, but the string wasn't cut.The device could not be removed temporarily.The user applied tension to the device and the string was broke.The intended procedure was completed with another device.There was no patient injury 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: 8076875
• MDR Text Key: 129314818
• Report Number: 8010047-2018-02215
• 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: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• 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: K2406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• 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