MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE INJECTOR NM600/610; INJECTOR AND SHEATHSET

Model Number NM-600L-0621

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

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946); Unspecified Tissue Injury (4559)

Event Date 11/21/2017

Event Type  Injury  

Manufacturer Narrative

Since the literature described "injection catheters (olympus japan) with 21 or 23g needles and a 6 mm long needle tip", olympus selected "nm-600l-0621" as a representative product.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.

Event Description

Olympus reviewed the following literature titled "procedure-related complications in gastric variceal obturation with tissue glue".The aim of this article was to focus on procedure-related complications, evaluate their incidence, analyze the reasons and discuss the solutions in 519 patients.Complications including sticking of the needle to the varix occurred in 9 cases (1.43%).The needle was successfully withdrawn in 8 cases.Large spurt bleeding occurred in one case, and hemostasis was achieved by two other injections of undiluted glue.The injection catheter became blocked in 17 cases (2.71%) just during the injection, and 4 cases were complicated with the needle sticking to the varix.Large glue adhesion to the endoscope resulted in difficulty withdrawing the endoscope in 1 case.This study concludes that egvo with tissue glue is usually safe and effective, a series of complications can occur during the procedure that may puzzle endoscopists.Type of adverse events/number of patients.Sticking of the needle to the varix - 9 patients.Blockage of the injection catheter - 17 patients.Glue adhesion to the endoscope resulted in difficulty withdrawing the endoscope - 1 patient.Ligation device sticking to the varices - 2 patients.This literature article requires 3 reports.The related patient identifiers are as follows: (b)(6)/gif-h260, (b)(6)/gif-h290, (b)(6)/nm-600l-0621.This medwatch report is for patient identifier (b)(6).

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 a correction to e4 to provide information that was inadvertently not included on the initial medwatch.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE INJECTOR NM600/610
• Type of Device: INJECTOR AND SHEATHSET
• 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: 16288203
• MDR Text Key: 308704528
• Report Number: 9614641-2023-00153
• Device Sequence Number: 1
• Product Code: FBK
• UDI-Device Identifier: 04953170377594
• UDI-Public: 04953170377594
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K153625
• 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: 02/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NM-600L-0621
• 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: 03/09/2023
• 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
• Patient Outcome(s): Required Intervention