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

Model Number TJF-260V

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Inflammation (1932)

Event Type  Injury  

Manufacturer Narrative

The malfunction of the subject device concerning this case has not been reported.Also, since the serial number of this device is unknown, olympus medical systems corp.(omsc) could not confirm the manufacturing history.Because the user facility recognized as accidental symptom in the conclusion of the report, this case may not be caused due to the malfunction of device.The exact cause of the reported event could not be conclusively determined.

Event Description

On october 12, 2017, olympus medical systems corp received a literature titled ¿experience of using spyglassds at the facility¿ that was made in public in 25th japan digestive disease week on october 2017.Complications after the pocs (peroral cholangioscopy) or pops (peroral pancreatoscopy) using olympus duodenoscope (tjf-260v) were reported in the literature.The literature reported pocs and pocs were performed by two person method in principal, and tjf-260v (duodenovideoscope manufactured by olympus) was concomitantly used with spyglassds (direct visualization system for cholangiopancreatoscopy, manufactured by boston scientific) as a master device.From november 2015 to february 2017, 18 cases were performed with spyglassds and tjf-260v, and 3 complications were reported.The breakdown of the 3 complications was 2 cases of cholangitis after ercp in cases of biliary stricture and 1 case of pancreatitis after ercp with ehl (electro hydraulic lithotripsy) in case of pancreatic stone.The symptoms were both light and relieved with conservative treatment.This is 1 of 3 reports.

• Brand Name: EVIS LUCERA DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 7016817
• MDR Text Key: 91913242
• Report Number: 8010047-2017-01738
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature,study,user facilit
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: TJF-260V
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/12/2017
• Initial Date FDA Received: 11/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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