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

Model Number JF-260V

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

Patient Problems Hemorrhage/Bleeding (1888); Pancreatitis (4481); Unspecified Hepatic or Biliary Problem (4493)

Event Type  Injury  

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

Olympus medical systems corp.(omsc) received a literature titled "endoscopic transpapillary gallbladder drainage for the management of acute calculus cholecystitis patients unfit for urgent cholecystectomy".Literature summary: this retrospective single-center study was aimed to evaluate the safety and efficacy of endoscopic transpapillary gallbladder drainage (etgbd) using via endoscopic transpapillary gallbladder stenting (etgbs) or endoscopic naso-gallbladder drainage (engbd), as either a bridge or a definitive treatment for patients with acc when cholecystectomy is delayed or cannot be performed.The study also examined the long-term etgbs outcomes.A total of 171 patients with acute calculus cholecystitis (acc) were included in the study who were retrospectively reviewed and evaluated for technical and clinical success rates and adverse events.The study also examined the predictive factors for technical success and the stent patency in the etgbs group with high surgical risks.In result, the reported technical and clinical success rates by intention-to-treat analysis for etgbd were 90.6% and 90.1%, respectively.While the adverse events occurred in 12.2% of patients but all were managed conservatively and/or with endoscopic treatment.Again, among the etgbs group, the median stent patency in 70 patients with high surgical risk was 503 days (interquartile range: 404.25¿775 days).In conclusion, the study said that etgbd, using either etgbs or engbd, was a suitable bridging option for acc patients unfit for urgent cholecystectomy.And also, in high surgical risk patients, etgbs may be a promising and useful treatment modality with low acc recurrence.Type of adverse events/number of patients: early adverse events: pancreatitis - (9), post est bleeding - (4).Late adverse events: acute cholangitis - (3).

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the author and the legal manufacturer's investigation.New information added to the following fields: event.The device history records (dhr) for this device could not be reviewed since the serial number was not provided.Olympus ships devices manufactured according to all applicable procedures and meet final product release criteria.A definitive root cause was not identified.Based on the available information, the legal manufacturer was unable to determine the probable cause of the adverse events since the device was not returned for evaluation.

Event Description

Additional information provided by the author: in the medical opinion of the author, after removing the stent, he said the adverse event was not related to the jf-260v scope at all and that there were no complaints or problems when using the scope.It is unclear which event the author is referencing.

• 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: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13939687
• MDR Text Key: 293537879
• Report Number: 8010047-2022-05230
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/03/2022

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-260V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/28/2022
• Initial Date FDA Received: 03/29/2022
• Supplement Dates Manufacturer Received: 04/06/2022
• Supplement Dates FDA Received: 05/04/2022
• Date Device Manufactured: 06/16/2019
• 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: VISIGLIDE GUIDEWIRES
• Patient Outcome(s): Other