MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. INJECTOR

Model Number NM-4U-1

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/17/2022

Event Type  Injury  

Event Description

Olympus reviewed the following literature titled, "usefulness of the combined orthodontic rubber band and clip method for gastric endoscopic submucosal dissection." background and aims: effective traction is an important prerequisite for successful endoscopic submucosal dissection (esd).The combined orthodontic rubber band (orb) and clip method was effective in colorectal cancer esd.To date, the method was not reported in gastric esd.This study aimed to investigate its efficacy and safety for gastric neoplasms esd.Methods: we retrospectively analyzed data of 118 patients with gastric neoplasms treated by esd from november 2020 to april 2022, 43 by orb-esd and 75 by the conventional esd.The primary outcome measure was the esd procedure time.Clinical data on efficacy and safety were also collected and analyzed.Propensity score matching (psm) matched the patients in both groups.Results: psm successfully matched 31 pairs of patients.The orb-esd operation time was shorter (median [interquartile range], 35 [30¿48] vs.49 [40¿70] min, p0.05).Conclusions: compared to the conventional esd, orb-esd significantly reduced the procedure time and increased the dissection speed, proving beneficial to gastric esd.Type of adverse events/number of patients: [orb-esd group] delayed bleeding - 1 patient, [conventional esd] delayed bleeding - 3 patients.This literature article requires 4 reports.The related patient identifiers are as follows: (b)(6) (nm-4u-1).(b)(6) kd-650l).(b)(6) (fd-410lr).(b)(6) (gif-q260j).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

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

The following additional information was received: there was no olympus device involved in the events described in the article.

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 new information added to b5.Olympus will continue to monitor field performance for this device.

• Brand Name: INJECTOR
• Type of Device: INJECTOR
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16464029
• MDR Text Key: 310497224
• Report Number: 9614641-2023-00281
• Device Sequence Number: 1
• Product Code: FBK
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K011484
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NM-4U-1
• 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: 03/06/2023
• 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
• Treatment: NON-OLYMPUS DEVICE - CLIP; NON-OLYMPUS DEVICE - KNIFE (MK-T-2-195); NON-OLYMPUS DEVICE - TRANSPARENT CAP; NON-OLYMPUS DEVICE - VIO200S (GENERATOR)
• Patient Outcome(s): Other