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

Model Number GF-UCT260

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 gallbladder drainage for acute cholecystitis with high risk surgical patients between trans-duodenal and transpapillary stenting¿, patients in both study groups experienced adverse effects during or after procedures using either a evis lucera ultrasound gastrovideoscope (the eus-gbd group) or an evis lucera duodenovideoscope (the et-gbd group).Study aim: eus guided gallbladder drainage (gbd) has emerged as an alternative gbd technique, particularly for high risk surgical patients.To prevent stent migration or to facilitate stent deployment, the lumen apposing metal stent (lams) was recently developed for eus gbd.However, lams remains unavailable in several countries and is expensive compared with conventional fully covered self expandable metal stent (fcsems).Although several studies have shown the clinical benefits of eus gbd using novel fcsems or lams compared with endoscopic transpapillary gbd (etgbd), the choice between etgbd and eus gbd using conventional fcsems and etgbd remains controversial.The aim of this study was to evaluate eus gbd using conventional fcsems compared with etgbd.Study method: comparative retrospective study including consecutive symptomatic acute cholecystitis (ac) patients who underwent gallbladder drainage by either eus-gbd or etgbd between january 2015 and december 2018.The main outcome measures were technical success, clinical success, procedure-related and stent-related adverse events, and recurrence of ac during follow-up.Results: fifty four patients (44.4% female, 55.6% male) who underwent eus gbd (n = 25) or etgbd (n = 29) were enrolled.Initial technical success rates were 100% with eus gbd and 82.7% (24/29) with etgbd.The median procedure time was significantly shorter for the eus gbd group than for the etgbd group (11.0 vs.24.0 min, p< 0.05).Procedure related adverse events did not differ significantly between groups (p = 0.283).During follow up (median 522 days, range 43 ¿ 1892 days), recurrent acute cholecystitis (ac) was only observed in 4 patients from the etgbd group.Overall survival did not differ significantly between the eus gbd group (mean 1070 days) and etgbd group (mean 1470 days) (p = 0.292).Conclusions: the technical success rate for eus gbd using fcsems with plastic stent insertion was significantly higher with a shorter procedure time and resulted in a lower rate of recurrent ac.Case with patient identifier (b)(6) reports the eus-gbd group (evis lucera ultrasound gastrovideoscope).Case with patient identifier (b)(6) reports the et-gbd group (evis lucera duodenovideoscope).In the eus-gbd group, one patient experienced a procedure related adverse event: pneumoperitoneum (treatment not specified).In the et-gbd group, three patients experienced procedure-related adverse events: one patient experienced cholangitis, and two patients experienced acute pancreatitis (treatment unspecified).There was no report of olympus device malfunction in any procedure described in this literature.

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 serial 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 ULTRASOUND GASTROVIDEOSCOPE
• Type of Device: ULTRASOUND GASTROVIDEOSCOPE
• 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: 13753585
• MDR Text Key: 291963297
• Report Number: 8010047-2022-04355
• Device Sequence Number: 1
• Product Code: ODG
• 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: 04/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GF-UCT260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/31/2022
• 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
• Patient Outcome(s): Other