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

Model Number TJF-Q290V

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

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001); Pancreatitis (4481); Unspecified Hepatic or Biliary Problem (4493)

Event Date 02/18/2021

Event Type  Injury  

Event Description

Olympus reviewed the literature titled "incidence and management of cystic duct perforation during endoscopic transpapillary gallbladder drainage for acute cholecystitis" by kazunari nakahara, et al.This retrospective single-center study was aimed to investigate the incidence of cystic duct perforation (cdp) as a specific adverse event during the endoscopic transpapillary gallbladder drainage (etgbd) procedure, also the management and the clinical outcome of cdp during etgbd.Out of 249 consecutive patients with acute cholecystitis (ac) included who underwent etgbd, cdp was observed in 23 (9.2%) patients and was caused by the gw and cannula, with no perforations by stents or catheters.The study reported technical success rate was 53.5% (8/15) for cdp caused by gws and 25.0% (2/8) for cdp caused by cannulas with a reported rate of technical success was 53.5% (8/15) for cdp caused by gws and 25.0% (2/8) for cdp caused by cannulas.The study also claimed that etgbd technical success rates, procedure times, and hospitalization periods were significantly inferior in the cdp group (n = 23) compared with the non-cdp group (n = 216).In conclusion, the cdp reduced the etgbd technical success rate.However, even in patients with cdp, an improvement of ac was achieved by subsequent successful etgbd or additional procedures.Adverse events: cdp group: -acute pancreatitis (mild and moderate severity in one each); both improved with conservative treatment.(n=2) -cdp during etgbd, caused by guidewire (n=15): an improvement of acute cholecystitis was achieved by subsequent successful etgbd or additional procedures, such as percutaneous drainage.Cdp was defined as the dislocation of devices, such as gw or cannula, or the leakage of contrast media into the peritoneal cavity from the cystic duct lumen confirmed by fluoroscopic imaging.Non-cpd group: pancreatitis (11), bleeding (1).This article includes 2 reports for the olympus devices and reported adverse events: (b)(6): jf-260v or tjf-260v, evis lucera duodenovideoscope.Jf-260v was selected as a representative device.(b)(6): tjf-q290v, evis lucera elite duodenovideoscope.This is report 2 of 2 for (b)(6): tjf-q290v, evis lucera elite duodenovideoscope.

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.The literature article is attached for additional information.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.Correction and preventative action (capa) investigation has been opened to further investigate this issue.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the relationship between the device and the adverse event cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA ELITE 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: 13771088
• MDR Text Key: 292494216
• Report Number: 8010047-2022-04450
• 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,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/13/2022

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: TJF-Q290V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/16/2022
• Initial Date FDA Received: 03/15/2022
• Supplement Dates Manufacturer Received: 05/24/2022
• Supplement Dates FDA Received: 06/13/2022
• 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
• Removal/Correction Number: Z-1292-2021
• Patient Sequence Number: 1
• Treatment: UNKNOWN VISIGLIDE
• Patient Outcome(s): Required Intervention; Other