MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS LUCERA DUODENOVIDEOSCOPE

Model Number JF-260V

Device Problem Failure to Cut (2587)

Patient Problem Burn(s) (1757)

Event Date 11/16/2017

Event Type  Injury  

Manufacturer Narrative

The subject device was returned to omsc for evaluation.During the evaluation, omsc confirmed asperity on a part of the forceps elevator of this device, but no other irregularity was confirmed.Also, omsc reviewed the manufacturing history of this device and confirmed no irregularity.The cause of the asperity of the forceps elevator is considered to be the possibility of spark due to the high-frequency cauterization treatment under the condition that the electrosurgical accessory was inside this device or the vicinity of the distal end of this device.However, the exact cause of the reported event could not be conclusively determined.

Event Description

Olympus medical systems corp.(omsc) was informed that when the procedure for therapeutic using the subject device was completed and this device was withdrawn from the patient's body, the user facility noticed that the area around the papilla of the patient became white like burns.The user facility reported that during endoscopic sphincterotomy using the electrosurgical accessory made by olympus (kd-v411m-0725) in combination with this device, the papilla has not been cut easily and replacement of the electrosurgical unit was carried out.The physician stated that this phenomenon may be related to papillotomy.No additional treatment was done for burns of the patient, and this case became a follow-up.

Manufacturer Narrative

This supplemental report is submitted to correct "device product code.".

• Brand Name: EVIS LUCERA DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• Manufacturer Contact: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 7103617
• MDR Text Key: 94352308
• Report Number: 8010047-2017-01965
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: JF-260V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other