MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SURGICAL SCISSORS

Model Number FS-3L-1

Device Problem Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2018

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus medical systems corp (omsc).Omsc evaluated it on nov.15, 2018, and found as follows; the device was cut off at the insertion part.There were no irregularities except the cutting off of the insertion part.The manufacturing record was reviewed and found no irregularities.This type of the event is most likely related to the operator's handling.The intended use of the device is "to cut tissue within the digestive tract", not to cut the thread.Omsc assumed that the event occurred due to the user tried to cut the thread.The instruction manual of the device has already warned as follows; do not use the instrument to cut any objects other than the target tissue (e.G., stents, metallic stent wires, sewing threads, and loops).If anything other than the tissue is cut, the blades may be damaged or the cut object may be caught in the tip of the instrument, and it may become difficult to safely remove the instrument from the body.

Event Description

During a mucos application after esd using dental floss as a sewing thread, the subject device was used.The user tried to cut the thread by using the device.The thread was caught in the blades of the device and the user could not remove the device from the patient's body.The user used a plier to cut the insertion part of the device and retrieved it from the patient.There was no patient injury reported.This is the report regarding the failure of the thread cutting.

Manufacturer Narrative

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

• Brand Name: SURGICAL SCISSORS
• Type of Device: SURGICAL SCISSORS
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 8093328
• MDR Text Key: 129327073
• Report Number: 8010047-2018-02240
• Device Sequence Number: 1
• Product Code: PTS
• Combination Product (y/n): N
• PMA/PMN Number: K955065
• 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: 11/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FS-3L-1
• Device Lot Number: 87K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2018
• 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