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

Model Number FS-5U-1

Device Problems Entrapment of Device (1212); Failure to Cut (2587); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2019

Event Type  malfunction  

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 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
• 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: 9706324
• MDR Text Key: 200658523
• Report Number: 8010047-2020-01329
• Device Sequence Number: 1
• Product Code: PTS
• UDI-Device Identifier: 04953170033445
• UDI-Public: 04953170033445
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: CLASS1-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FS-5U-1
• Device Lot Number: 96K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 37 YR