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

Model Number GIF-Q260J

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

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001); Insufficient Information (4580)

Event Date 09/02/2021

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 reviewed a literature titled "the value of endoscopic ultrasonography in the endoscopic resection of gastrointestinal stromal tumors".This retrospective, single-center study was aimed to explore the clinical value of endoscopic ultrasonography (eus) in the endoscopic resection of gastrointestinal stromal tumors (gists).A total of 92 patients were included were underwent endoscopic treatment, of which 89 (96.7%) patients underwent complete pathological resection.Of these 92 patients, 37 (40.2%) underwent endoscopic submucosal dissection (esd), 27 (29.4%) underwent endoscopic submucosal excavation (ese), 15 (16.3%) underwent endoscopic full-thickness resection (eftr), nine (9.8%) underwent endoscopic band ligation (ebl), and four (4.3%) underwent submucosal tunneling endoscopic resection (ster).The study reported a 78.7% rate for preoperative diagnosis rate of eus and postoperative pathological diagnosis of gists.The presence of a non-homogeneous echo and liquid anechoic zone in gists often indicated higher risk (p < 0.05).The study concluded that endoscopic resection of gists is feasible and safe.Eus is of great significance for the diagnosis and risk assessment of gists and can assist in the endoscopic resection of gists.The authors used 5 olympus devices: dual-knife (kd-655l or kd-655q), it-knife (kd-612l), hyaline cap (d-201-11804), and gif-q260j and reported the following: complications: intraoperative bleeding occurred in two patients (2.2%), and both of these cases occurred during ese.Thermal biopsy forceps and titanium clamps were successfully used to stop the bleeding.Perforation occurred in 13 patients (14.1%; cases of perforation during eftr were not included), three of which occurred during ebl, six during esd, and four during ese.These perforations were successfully closed with titanium clips, titanium clips combined with a purse-string suture, or otscs®.After the procedure, electrocoagulation syndrome occurred in seven patients (two cases after esd, two after ese, and three after eftr).All the patients improved after conservative treatments, such as the deprivation of food and water, rehydration, or rational intravenous use of antibiotics.Postoperative perforation occurred in one patient undergoing esd, and the patient improved after surgery.The physician's medical opinion upon follow up stated no adverse events were linked to the olympus devices.This article includes 4 reports: (b)(6): kd-612l.(b)(6): kd-655l or kd-655q.(b)(6): d-201-11804.(b)(6): gif-q260j.This report is 4 of 4 for (b)(6): gif-q260j.

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 GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• 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: 14160447
• MDR Text Key: 289665677
• Report Number: 8010047-2022-06680
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K954451
• 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: 06/08/2022

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: GIF-Q260J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/21/2022
• Initial Date FDA Received: 04/20/2022
• Supplement Dates Manufacturer Received: 05/23/2022
• Supplement Dates FDA Received: 06/08/2022
• 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: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN LOT NUMBERS: KD-612L,KD-655L.; UNKNOWN LOT NUMBERS: KD-655Q,D-201-11804.
• Patient Outcome(s): Other; Required Intervention