MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ROTATABLE CLIP FIXING DEVICE; LIGATOR, ESOPHAGEAL

Model Number HX-201LR-135

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

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001); Unspecified Tissue Injury (4559)

Event Date 02/24/2021

Event Type  Injury  

Event Description

Olympus reviewed the following literature titled "the risk factors for prolonged hemostatic clip retention after endoscopic submucosal dissection for gastric neoplasm." the aim of this study was to investigate the factors associated with prolonged hemoclip retention with gastric endoscopic submucosal dissection (esd) induced ulcers.A total of 199 patients were analyzed.The en-bloc resection rate was 87.9%, the complete resection rate was 92.5%, and submucosal invasion was confirmed in 8.5% of the cases.The mean procedure time was 60.6±38.0 min.The mean number of hemoclips was 3.7±2.5, while there was no difference in the number of applied clips depending upon the location of the lesion.By kaplan¿meier survival analysis, clips at the antrum detached significantly earlier than those at other locations (p=0.011).In conclusion, most of the attached hemostatic clips during esd were spontaneously removed by 3 months after gastric esd.Type of adverse events/number of patients.Bleeding - 89.7%, microperforations - 16 patients, repair of partial muscular tears - 4 patients.The event date was reported as the publication date of the literature.This literature article requires 7 reports.The related patient identifiers are as follows: -(b)(6):kd-650l.-(b)(6):fd-410lr.-(b)(6):hx-110lr.-(b)(6):hx-5lr-1.-(b)(6):hx-201lr-135.-(b)(6):gif-h260.-(b)(6):gif-h290.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.The literature article is attached for additional information.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to provide follow up received from the author.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 events 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.Olympus will continue to monitor field performance for this device.

Event Description

The author confirms there were no olympus device malfunction and no olympus device caused or contributed to any of the patient adverse event.

• Brand Name: SINGLE USE ROTATABLE CLIP FIXING DEVICE
• Type of Device: LIGATOR, ESOPHAGEAL
• 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: 16938970
• MDR Text Key: 315295815
• Report Number: 9614641-2023-00676
• Device Sequence Number: 1
• Product Code: MND
• UDI-Device Identifier: 04953170192999
• UDI-Public: 04953170192999
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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,Followup
• Report Date: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HX-201LR-135
• 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: 05/25/2023
• 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