MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION SINGLE USE 3-LUMEN SHINCTEROTOME

Model Number KD-V411M-0725

Device Problem Energy Output To Patient Tissue Incorrect (1209)

Patient Problem Death (1802)

Event Date 06/02/2015

Event Type  Death  

Event Description

Olympus medical systems corp.(omsc) was informed that during endoscopic sphincterotomy (est), although the doctor activated the output the papilla was burnt white and it was difficult to cut the papilla.When the doctor put the foot switch noise appeared on an endoscopic image and the blackout occurred.As a result of using another device, the doctor could complete the procedure.Reportedly, the patient developed pancreatitis and died from it at a later date.The doctor reported that he was aware that pancreatitis was complication of est.

Manufacturer Narrative

The subject device was returned to omsc for investigation.The investigation confirmed that the coating on the cutting wire was torn and the exposed cutting wire from the damaged coating was partially burnt.As the checking of the manufacturing record of the same lot, nothing abnormal was detected.According to the investigation, omsc assumes that the damage of the coating occurred due to contacting with the forceps elevator of the endoscope.The exposed cutting wire contacted to the distal end of the endoscope while activating the output, which caused leakage current to the endoscope and noise on the endoscope image.In addition, that led to decreased output.The doctor said that trying to cut patient's papilla many times could be one of the factors which contributed to the pancreatitis.According to the doctor's comment, omsc thinks that the user handling led to the pancreatitis.This report is being submitted as a medical device report in an abundance of caution.

• Brand Name: SINGLE USE 3-LUMEN SHINCTEROTOME
• Type of Device: SHINCTEROTOME
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION; 2951 ishikawa-cho; hachioji-shi 192- 8507; JA 192-8507
• Manufacturer Contact: susumu nishina ; 2951 ishikawa-cho; hachioji-shi 192-8-507 ; JA 192-8507
• MDR Report Key: 4874940
• MDR Text Key: 6048610
• Report Number: 8010047-2015-00547
• Device Sequence Number: 1
• Product Code: KNS
• 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: 06/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: KD-V411M-0725
• Device Lot Number: K5119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death