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

Model Number JF-230

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pancreatitis (4481)

Event Type  Injury  

Event Description

It is reported in the literature titled "endoscopic transpapillary bile duct biopsy with the combination of intraductal ultrasonography in the diagnosis of biliary strictures" using an evis duodenovideoscope, one patient experienced acute pancreatitis.Study aim: to evaluate the value of intraductal ultrasonography (idus) when bile duct biopsy is negative.Study method: prospective study of 62 patients with strictures of the bile duct were studied.Y.During endoscopic retrograde cholangiopancreatography (ercp), idus was performed using an ultrasonic probe (diameter 2.0 mm; frequency 20 mhz).Following idus, a bile duct biopsy was performed using forceps (diameter 1.8 mm).The idus images of the tumor were classified as polypoid lesions, localized wall thickening, intraductal sessile tumors, sessile tumor outside of the bile duct, or absence of apparent lesion.The bile duct wall structures at the site of the tumor as well as the maximum diameter of the tumor were also analyzed.The idus findings were compared with the histological findings or clinical course.Results: when the idus images showed a polypoid lesion (n=19), localized wall thickening (n=8), intraductal sessile tumor (n=13), and sessile tumor outside of the bile duct (n = 20), the sensitivities of the biopsy were 80%, 50%, 92%, and 53%, respectively.Multiple regression analysis showed that the presence of sessile tumor (intraductal or outside of the bile duct: p 0.05), tumor size greater than 10.0 mm (p 0.001), and interrupted wall structure (p 0.05) were independent variables that predicted malignancy.Conclusion: when biopsy fails to demonstrate evidence of malignancy, the presence of sessile tumor (intraductal or outside of the bile duct), tumor size greater than 10.0 mm, and interrupted wall structure on idus images are factors that can predict malignancy.Complications: one patient suffered from acute pancreatitis which resolved within 48 hours with intravenous fluids and analgesia.No other complications occurred as a result of ercp, idus, biopsy, or enbd.There is no report of any olympus device malfunction in any procedure described in this study.

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

It is reported in the literature titled "endoscopic transpapillary bile duct biopsy with the combination of intraductal ultrasonography in the diagnosis of biliary strictures" using an evis duodenovideoscope, one patient experienced acute pancreatitis.Study aim: to evaluate the value of intraductal ultrasonography (idus) when bile duct biopsy is negative.Study method: prospective study of 62 patients with strictures of the bile duct were studied.Y.During endoscopic retrograde cholangiopancreatography (ercp), idus was performed using an ultrasonic probe (diameter 2.0 mm; frequency 20 mhz).Following idus, a bile duct biopsy was performed using forceps (diameter 1.8 mm).The idus images of the tumor were classified as polypoid lesions, localized wall thickening, intraductal sessile tumors, sessile tumor outside of the bile duct, or absence of apparent lesion.The bile duct wall structures at the site of the tumor as well as the maximum diameter of the tumor were also analyzed.The idus findings were compared with the histological findings or clinical course.Results: when the idus images showed a polypoid lesion (n=19), localized wall thickening (n=8), intraductal sessile tumor (n=13), and sessile tumor outside of the bile duct (n = 20), the sensitivities of the biopsy were 80%, 50%, 92%, and 53%, respectively.Multiple regression analysis showed that the presence of sessile tumor (intraductal or outside of the bile duct: p 0.05), tumor size greater than 10.0 mm (p 0.001), and interrupted wall structure (p 0.05) were independent variables that predicted malignancy.Conclusion: when biopsy fails to demonstrate evidence of malignancy, the presence of sessile tumor (intraductal or outside of the bile duct), tumor size greater than 10.0 mm, and interrupted wall structure on idus images are factors that can predict malignancy.Complications: one patient suffered from acute pancreatitis which resolved within 48 hours with intravenous fluids and analgesia.No other complications occurred as a result of ercp, idus, biopsy, or enbd.There is no report of any olympus device malfunction in any procedure described in this study.

Manufacturer Narrative

This report is being supplemented to provide additional information, based on the legal manufacturer's final investigation.No device was sent for evaluation.And a serial number was not provided.Complaint information provided the basis of this investigation.The dhr was unable to be reviewed for this device, since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The case is not, due to design.Based on the results of the investigation, a definitive root cause could not be established.The case was a study report ¿endoscopic transpapillary bile duct biopsy with the combination of intraductal ultrasonography in the diagnosis of biliary strictures¿.Since the device was not sent to olympus, the device was not analyzed.As no device was alleged with default with this report, no cause was deemed applicable - ergo, no device problem was identified.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS 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: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13534288
• MDR Text Key: 285610697
• Report Number: 8010047-2022-02959
• 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: Other,Foreign,Study,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/25/2022

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: Health Professional
• Device Model Number: JF-230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/17/2022
• Initial Date FDA Received: 02/15/2022
• Supplement Dates Manufacturer Received: 02/28/2022
• Supplement Dates FDA Received: 03/25/2022
• 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
• Treatment: FB-39Q
• Patient Outcome(s): Required Intervention; Other