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

Model Number TJF-Q180V

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 03/09/2020

Event Type  Injury  

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.This event has been reported by the importer on mdr# 2951238 ¿ 2022- 00370.

Event Description

It is reported in the literature titled ¿endoscopic ultrasound-directed transgastric ercp (edge): a retrospective multicenter study,¿ patients experienced adverse events during or after procedures using olympus duodenoscopes.Case with patient identifier (b)(6) reports the tjf-q180v used in the edge procedures case with patient identifier (b)(6) reports the "slim" duodenoscope used in the edge procedures (either jf-q140v, jf-q160v, or jf-q180v).Background and aims: endoscopic ultrasound-directed transgastric endoscopic retrograde cholangiopancreatography (ercp; edge) is an alternative to enteroscopy- and laparoscopy-assisted ercp in patients with roux-en-y gastric bypass anatomy.Although short-term results are promising, the long-term outcomes are not known.The aims of this study were: (1) to determine the rates of long-term adverse events after edge, with a focus on rates of persistent gastrogastric or jejunogastric fistula; (2) to identify predictors of persistent fistula; (3) to assess the outcomes of endoscopic closure when persistent fistula is encountered.Method: multicenter retrospective study involving 13 centers between february 2015 and march 2019.Adverse events were defined according to the asge lexicon.Persistent fistula was defined as an upper gastrointestinal series or esophagogastroduodenoscopy showing evidence of fistula.Results: 178 patients (mean age 58 years, 79 % women) underwent edge.Technical success was achieved in 98 % of cases (175/178), with a mean procedure time of 92 minutes.Periprocedural adverse events occurred in 28 patients (15.7 %; mild 10.1 %, moderate 3.4 %, severe 2.2 %).The four severe adverse events were managed laparoscopically.Persistent fistula was diagnosed in 10 % of those sent for objective testing (9/90).Following identification of a fistula, 5 /9 patients underwent endoscopic closure procedures, which were successful in all cases.Conclusions: the edge procedure is associated with high clinical success rates and an acceptable risk profile.Persistent fistulas after lumen-apposing stent removal are uncommon, but objective testing is recommended to identify their presence.When persistent fistulas are identified, endoscopic treatment is warranted, and should be successful in closing the fistula there were 28 early adverse events that occurred following edge (15.7 % of all cases), with 22 events attributable to the eus access and six attributable to the ercp.Events attributable to ercp (n = 6) were mild (n = 3) or moderate (n = 3) in severity, according to the asge lexicon.Events attributable to eus (n = 22) were predominantly mild (n = 15) or moderate (n = 3) in severity, although there were four severe events, three of which involved laparoscopic intervention and one of which involved a prolonged hospital stay following the procedure.These rates are comparable with those found in the existing literature.There is no report of olympus device malfunction described in this study.

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 EXERA II 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: 14021382
• MDR Text Key: 288664562
• Report Number: 8010047-2022-05773
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170339967
• UDI-Public: 04953170339967
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Literature,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/27/2022

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-Q180V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/08/2022
• Initial Date FDA Received: 04/06/2022
• Supplement Dates Manufacturer Received: 05/16/2022
• Supplement Dates FDA Received: 05/27/2022
• 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-0379-2022
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other