MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. UNKNOWN, EMR KIT; GASTROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number UNKNOWN

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

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001)

Event Date 06/16/2022

Event Type  Injury  

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.This report has been submitted by the importer under this mdr report number 2429304-2022-00079.

Event Description

Olympus reviewed the following literature titled "the conundrum in endoscopic management of duodenal polyps: a tertiary cancer center experience." endoscopic mucosal resection of duodenal polyps (emr) is a challenging intervention.The aim of this study was to review the patient characteristics, techniques, procedure outcomes, adverse events, and recurrence of duodenal polyps.Research design and methods: patients were included if they had pathologically confirmed nonampullary duodenal polyps and had received emr with at least one follow-up egd for surveillance.Descriptive statistics were employed to report the findings.Results: a total of 65 patients underwent a total of 90 emrs for duodenal polyps.The mean age was 65.4 years, and 29 of the patients were female.Complete resection of the visible mass was achieved in 96.9% of cases.Endoscopic hemostasis was required in 18.5% of patients.Delayed bleeding occurred in 9%, and delayed perforations requiring surgical intervention occurred in 2.2% of patients with no mortality.Surgery after emr was needed in 12.7% of cases.Eleven (16.9%) patients had recurrent duodenal adenoma on follow-up egd.Conclusion: duodenal polyps can be safely resected and have a notable recurrence rate.This is particularly true for adenomas, warranting post-resection endoscopic surveillance.The appropriate interval for post-resection surveillance of duodenal adenomas should be a focus of future study.Adverse events: bleeding 12 patients.Delayed perforation 2 patients.Delayed bleeding 6 patients.This literature article requires 4 reports.The related patient identifiers are as follows: (b)(6) gif-q180, evis exera ii gastrointestinal videoscope.(b)(6) tjf-160f, evis exera duodenovideoscope.(b)(6) maj-935, probe driving unit.(b)(6) unknown, emr kit.This medwatch report is for patient identifier (b)(6).There is no report of any olympus device malfunction in any procedure 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 serial and/or 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.Therefore, the root cause cannot be determined.This supplemental report includes information added to e4 an g2.Olympus will continue to monitor field performance for this device.

• Brand Name: UNKNOWN, EMR KIT
• Type of Device: GASTROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15589113
• MDR Text Key: 301590981
• Report Number: 9614641-2022-00458
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN(LITERATURE)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN SERIAL, GIF-Q180,TJF-160F; UNKNOWN SERIAL, MAJ-935
• Patient Outcome(s): Required Intervention; Hospitalization; Other