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

Model Number FS-5U-1

Device Problem Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 06/24/2019

Event Type  Injury  

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.A supplemental report will be submitted, if additional or significant information becomes available at a later time.

Event Description

The national competent authority (b)(6) informed olympus medical systems corp.(omsc) the following event on december 23, 2019.During an endoscopy to cut a wire mersuture intra-gastric in the cardiac area, the subject device was used.The loop cutter was closed over the wire to cut it.After this first closing, the loop cutter did not cut the wire and moreover remained stuck on the wire, making it impossible to open the scissor.The loop cutter was finally broken and left in the patient, the endoscope was removed.Another pair of forceps was inserted into the endoscope, which also failed to cut the wire.A surgeon was called and the conversion was considered.The intervention time was more than 60 minutes.No further information was provided.

Manufacturer Narrative

This is a supplemental report to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.The lot number of the subject device is unknown.As a result of checking the manufacturing record for past one year from the event date, it was found no irregularities.Based on the reported information, it was known that this event likely occurred since the user tried to cut the object which was outside of the intended use.Consequently, the user could not cut the object and the subject device got stuck and broken.The above device handling has warned in the instruction manual as follows.This instrument has been designed to be used with an olympus endoscope.It is used to cut the residual end of the olympus loop used for ligating tissue within the digestive tract.Do not use this instrument for any other purpose.

• Brand Name: LOOP CUTTER
• Type of Device: LOOP CUTTER
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 9585301
• MDR Text Key: 187257634
• Report Number: 8010047-2020-00889
• Device Sequence Number: 1
• Product Code: PTS
• Combination Product (y/n): N
• PMA/PMN Number: CLASS1-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FS-5U-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other