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

Model Number	FS-5U-1
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.The cause of the reported event cannot be determined at this time.The instruction manual of the device has already warned as follows; ¿do not try to cut the loop that is not positioned on both edges of the loop hanger as plumb as possible for the blade.It may make cutting the loop impossible, or result in the loop getting caught in the distal end of the instrument, which could make it difficult or impossible to remove from the patient.In this case, use pliers to cut the insertion portion of the instrument where it extends from the biopsy valve of the endoscope.Remove the endoscope from the body, then reinsert the endoscope and cut the loop with a spare loop cutter.¿.
Event or Problem Description
Olympus was informed that during an unspecified procedure, the surgeon was using the loop cutter to remove a bronchial stent by its¿ lasso, when it became stuck.The user cut the insertion part of the device.The user removed the endoscope from the patient while leaving the device inside the patient.The user inserted a 4mm endoscope and used an endoscopic camera, with a laparoscopic scissor to cut the string and removed the remaining portion of the loop cutter device from the patient.The intended procedure to remove the stent was then completed.

• Brand Name: LOOP CUTTER
• Common Device Name: 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: 8380648
• Report Number: 2951238-2019-00475
• Device Sequence Number: 18939993
• Product Code: FCL
• UDI-Device Identifier: 04953170033445
• UDI-Public: 04953170033445
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K955065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FS-5U-1
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2019
• Initial Report FDA Received Date: 02/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1