MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION LOOP CUTTER

Model Number FS-5L-1

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/28/2014

Event Type  malfunction  

Event Description

Olympus medical systems corp (omsc) was informed that the doctor attempted to place an esophageal stent manufactured by (b)(4) to the patient and cut its band using the subject device.Then the band was stuck in the cutter and the doctor could not temporarily withdraw the device from the patient.The doctor burned off the band with a laser and withdrew the device from the patient.The procedure was completed with another device.There was no report of patient injury regarding this report.

Manufacturer Narrative

The subject device was returned to omsc for investigation, the investigation confirmed that the band was stuck in the cutter part.When removing it from cutter part, the cutter opened and closed smoothly.The cutter was not deformed and as the result of checking the manufacturing record of the same lot, nothing abnormal was detected.Thus, omsc considers that cutting the band of the stent caused this event.This report is being submitted as a medical device report in an abundance of caution.

• Brand Name: LOOP CUTTER
• Type of Device: LOOP CUTTER
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: hiroki moriyama ; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 26425177
• MDR Report Key: 3931343
• MDR Text Key: 20326155
• Report Number: 8010047-2014-00169
• Device Sequence Number: 1
• Product Code: HIN
• 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 Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/28/2014

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
• Device Operator: Health Professional
• Device Model Number: FS-5L-1
• Device Lot Number: K2Y30-0154
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/07/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2014
• Initial Date FDA Received: 04/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2002
• Is the Device Single Use?: No
• Patient Sequence Number: 1