MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. ROTATABLE CLIP FIXING DEVICE

Model Number HX-110UR

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

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

Event Date 10/21/2023

Event Type  Injury  

Manufacturer Narrative

E1/establishment name: (b)(6) added here due to character limitation in respective field.Since the literature described "ezclip", olympus selected "hx-110ur" as a representative product.This report is related to the following linked patient identifiers: (b)(6).Attempts were performed to obtain additional information, but no response was received.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

Olympus reviewed the following literature titled "conventional versus underwater endoscopic resection for superficial non-ampullary duodenal epithelial tumours." literature summary: abstract: background and objective: several endoscopic resection methods have been developed as less invasive treatments for superficial non-ampullary duodenal epithelial tumours.This study aimed to compare outcomes of conventional endoscopic mucosal resection and underwater endoscopic mucosal resection for superficial non-ampullary duodenal epithelial tumours, including resection depth and rate of the muscularis mucosa contained under the lesion.Methods: this single-centre retrospective cohort study conducted from january 2009 to december 2021 enrolled patients who underwent conventional endoscopic mucosal resection and underwater endoscopic mucosal resection for superficial non-ampullary duodenal epithelial tumours and investigated their clinicopathological outcomes using propensity score matching.Results: of the 285 superficial non-ampullary duodenal epithelial tumours, 98 conventional endoscopic mucosal resections and 187 underwater endoscopic mucosal resections were included.After propensity score matching, 64 conventional endoscopic mucosal resections and 64 underwater endoscopic mucosal resections were analysed.The r0 resection rate was significantly higher in underwater endoscopic mucosal resection cases than in conventional endoscopic mucosal resection cases (70.3% vs.50.0%; p = 0.030).In the multivariate analysis, a lesion diameter greater than 10 mm (odds ratio 7.246; p = 0.001), being in the 1st¿50th treatment period (odds ratio 3.405; p = 0.008), and undergoing conventional endoscopic mucosal resection (odds ratio 3.617; p = 0.016) were associated with rx/r1 resection.Furthermore, in underwater endoscopic mucosal resection cases, the r0 rate was significantly higher for lesions diameter =10 mm than greater than 10 mm, and was significantly higher in the 51st-treatment period than in the 1st¿50th period.Conventional endoscopic mucosal resection and underwater endoscopic mucosal resection cases showed no significant difference in resection depth and muscularis mucosa containing rate.Conclusions: underwater endoscopic mucosal resection may be more acceptable than conventional endoscopic mucosal resection for superficial non-ampullary duodenal epithelial tumours = 10 mm.A steep early learning curve may be acquired for underwater endoscopic mucosal resection.Large multicentre prospective studies need to be conducted to confirm the effectiveness of underwater endoscopic mucosal resection.Type of adverse events/number of patients: delayed perforation: 2.Delayed bleeding: 1.One case of delayed perforation required surgical treatment in the conventional endoscopic mucosal resection (c-emr) group.The case of delayed bleeding was successfully treated with endoscopic hemostasis in the underwater endoscopic mucosal resection (uemr) group.

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 additional information received from the author.B5 updated accordingly.Also, a correction has been made to h8 from the initial medwatch.Olympus will continue to monitor field performance for this device.

Event Description

An olympus device did not cause or contribute to the adverse events described in the article.Also, it was confirmed that there was no malfunction of an olympus device.

• Brand Name: ROTATABLE CLIP FIXING DEVICE
• Type of Device: ROTATABLE CLIP FIXING DEVICE
• 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 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18986061
• MDR Text Key: 338699301
• Report Number: 9614641-2024-00772
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 04953170200229
• UDI-Public: 04953170200229
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K013066
• 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
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HX-110UR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/29/2024
• 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
• Patient Outcome(s): Required Intervention