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

Model Number HX-610-090

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

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

Event Date 12/06/2021

Event Type  Injury  

Event Description

Olympus reviewed the following literature titled "usefulness of the clip-and-snare method using the pre-looping technique for endoscopic submucosal dissection of gastric neoplasia: a randomized controlled trial".This multicenter, randomized controlled trial aimed to assess the efficacy of clip-and-snare method using the pre-looping technique (csm-plt) in gastric endoscopic submucosal dissection (esd).A total of 378 patients were finally included in the per-protocol analysis.The mean procedure times were 69.7 and 58.0 min for the conventional esd and csm-plt groups, indicating that the procedure was significantly shorter in the csm-plt group (p=0.009).The r0 resection rate tended to be higher in the csm plt group than in the conventional esd group (p=0.09).The mean procedure time was significantly shorter in the novice (p=0.04), tumor size =20 mm (p=0.02), and it knife (p=0.045) groups.The mean preparation time for csm-plt was 2.3 min.Csm-plt method shortened the esd procedure time.Moreover, csm-plt is safe, does not increase complication rates, and is associated with better r0 resection rates than conventional esd.Type of adverse events/number of patients: perforation - 5.Delayed bleeding - 17.This literature article requires 10 reports.The related patient identifiers are as follows: 1.(b)(6)/d-201-11804; 2.(b)(6)/kd-611l; 3.(b)(6)/kd-650l; 4.(b)(6)/kd-620lr; 5.(b)(6)/kd-1l-1; 6.(b)(6)/kd-630l; 7.(b)(6)/fd-410lr; 8.(b)(6)/sd-221u-25; 9.(b)(6)/hx-610-090; 10.(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

Since the literature described "ez clip, hx-610-090", olympus selected "hx-610-090" as a representative product.The device history record was unable to be reviewed for this device since no product malfunction was reported.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, it is likely the reported event is an accident, or a complication associated with a surgical procedure using the subject device.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Olympus will continue to monitor field performance for this device.

• Brand Name: CLIP
• Type of Device: CLIP
• 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: 16918130
• MDR Text Key: 315074911
• Report Number: 9614641-2023-00658
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 04953170200298
• UDI-Public: 04953170200298
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K183590
• 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: 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HX-610-090
• 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: 04/17/2023
• 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; Other