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

Model Number FS-5U-1

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2019

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The suture was caught in the distal end of the subject device.As a result of removing the suture, there was no abnormalities on the subject device.The manufacturing record was reviewed and found no irregularities.Based on the past similar cases, it was known that the suture might get stuck in the subject device because the user tried to cut the suture.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.*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.*do not use the loop cutter to cut anything other than the loop.If you cut any other object, it may get caught in the distal end.This could make it difficult or impossible to remove it from the patient.

Event Description

During a therapeutic procedure, the subject device was used.When the user tried to cut a suture with the subject device, the suture got stuck in the blade of the device and the device could not be removed from the endoscope.Since the treatment part was near patient's anus, the user once withdrew the endoscope from the patient while the subject device was remained in the patient, and inserted an another endoscope.The user burnt off the suture with the hemostatic forceps and removed the device from the patient.There was no patient injury reported.This is the report regarding the failure of removing the subject device.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 8725750
• MDR Text Key: 148954216
• Report Number: 8010047-2019-02258
• Device Sequence Number: 1
• Product Code: PTS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: CLASS1-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2019
• 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: K9222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2019
• 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