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

Model Number FS-5L-1

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/26/2016

Event Type  malfunction  

Manufacturer Narrative

The subject device has not been returned to olympus medical systems corp.(omsc) for evaluation.The exact cause could not be conclusively determined.A supplemental report will be submitted, if additional and significant information becomes available at a later time.

Event Description

During an esophagoscopy, the doctor found that the endoscopic nasobiliary drainage tube was stuck in the suture.When the doctor tried to cut the suture with the subject device, the subject device was stuck in the suture.As a result, the doctor could not withdraw the subject device.The doctor severed the insertion portion of the subject device and withdrew the endoscope.After that, he inserted the endoscope again, and completed the intended procedure with another device.The fragment was retrieved.No patient injury was reported.

Manufacturer Narrative

This is a supplemental report for mfr report # 8010047-2016-01051 to provide additional information.The subject device was not returned to olympus medical systems corp (omsc) for evaluation, because it was already discarded.The lot no.Was unknown.Therefore, as the result of checking the manufacturing record of one year in the past from (b)(6) 2016 (delivery date), there was nothing abnormal detected.However, based on the reported situation, the event might be caused by unintended use in which the user tried to cut sewing threads.The instruction manual of the fs-5l-1 contains warning statements which does not cut sewing threads.Do not use the instrument to cut any objects other than the surplus of olympus loop (e.G., (b)(4)).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.

• Brand Name: LOOP CUTTER
• Type of Device: LOOP CUTTER
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: susumu nishina ; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 5861843
• MDR Text Key: 52743397
• Report Number: 8010047-2016-01051
• Device Sequence Number: 1
• Product Code: FJL
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FS-5L-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1