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

Model Number	FS-5U-1
Medical Device Problem Codes	Entrapment of Device (1212); Failure to Cut (2587); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the service center for evaluation.Therefore, the exact cause of the reported event cannot be determined.Upon return of the device, an evaluation will be performed, and a supplemental report will be submitted.
Event or Problem Description
A report was received at the service center for a loop cutter (fs-5u-1), lot number 96 k, that ¿stopped working, not cutting and got stuck¿ during a procedure.The loop cutter was not inspected prior to the procedure and was not reprocessed as it was the initial use of the device.The physician was performing a therapeutic retrieval of a bariatric ring when the loop cutter would not cut, remained closed and got stuck near the bariatric ring.The reported incident occurred at the beginning of the procedure and the device was removed from the patient.It was reported the patient was under general anesthesia and the procedure was prolonged past 90 minutes.In addition, it was reported there was no additional medical intervention, prolonged post-op observation or hospitalization provided to the patient.The loop cutter did not fall apart and no items fell into the patient.Another device was used to complete the procedure.A gastroscope from fujinom was also used in the procedure.It was reported there was no patient injury and the patient was fine with no problems in the post procedure.

• 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: 9706324
• Report Number: 8010047-2020-01329
• Device Sequence Number: 3675218
• Product Code: PTS
• UDI-Device Identifier: 04953170033445
• UDI-Public: 04953170033445
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: CLASS1-EXMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/13/2020

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: 96K
• 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: 01/28/2020
• Initial Report FDA Received Date: 02/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 37 YR