MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. DISPOSABLE DISTAL ATTACHMENT

Model Number D-201-13404

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/07/2023

Event Type  Injury  

Event Description

Olympus reviewed the following literature titled "standard endoscopic mucosal resection vs precutting endoscopic mucosal resection using novel disk-tip snare for colorectal lesions." literature summary introduction souten (kaneka co., tokyo, japan) is a unique snare with a disk tip.We analyzed the efficacy of precutting endoscopic mucosal resection with souten (pemr-s) for colorectal lesions.Methods we retrospectively reviewed 57 lesions of 10¿30 mm treated with pemr-s at our institution from 2017 to 2022.The indications were lesions that were difficult for standard emr due to size, morphology, and poor elevation by injection.Various therapeutic results of pemr-s such as en bloc resection, procedure time, and perioperative hemorrhage were analyzed, and the results of 20 lesions of 20¿30 mm with pemr-s were compared to those of lesions with standard emr (2012¿2014) using propensity score matching.Additionally, the stability of the souten disk tip was analyzed in a laboratory experiment.Regarding adverse events, perioperative hemorrhage was defined as continuous hemorrhage requiring hemostasis during mucosal incision.We also analyzed perioperative hemorrhage during mucosal incision, and it was divided into minor and major bleeding.Major bleeding was defined as those which disturbed subsequent mucosal incision.Results the polyp size was 16.5 ± 4.2 mm and the non-polypoid morphology rate was 80.7%.Histopathological diagnosis included 10 sessile-serrated lesions, 43 low-grade and high-grade dysplasias, and 4 t1 cancers.After matching, the en bloc resection and histopathological complete resection rates of lesions of 20¿30 mm between pemr-s and standard emr (90.0% vs.58.1%, p = 0.03 and 70.0% vs.45.0%, p = 0.11).The procedure time (min) was 14.8 ± 9.7 and 9.7 ± 8.3 (p < 0.01).The en bloc resection (%) and procedure time of expert/non-expert were 89.7/85.7 (p = 0.96) and 6.1 ± 2.2/18.5 ± 7.2 (p < 0.01).The perioperative bleeding and hemostasis success rates with souten were 43.9% and 96.0%.In the experiment, the souten disk tip was fixed stably compared to other emr snares.The perioperative bleeding rate was 43.9% (25/57), including 10 cases with minor bleeding and 15 cases with major bleeding.The success rate of hemostasis for perioperative hemorrhage with a disk tip of the snare was 96.0% (24/25).In a case of massively pulsative hemorrhage, successful hemostasis was not achieved with the disk tip by an expert.Hemostatic forceps was used to stop bleeding in this case.Conclusions pemr-s achieved high en bloc resection of colorectal lesions of 20¿30 mm though it leaded to long procedure time.Type of adverse events/number of patients perioperative bleeding - 25 cases 10 cases with minor bleeding 15 cases with major bleeding.

Manufacturer Narrative

This report is related to the following linked patient identifier: (b)(6).The device was not returned.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

An olympus device did not cause or contribute to the adverse events described in the article.Also, it was confirmed that an olympus device malfunction did not occur.

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.Olympus will continue to monitor field performance for this device.

• Brand Name: DISPOSABLE DISTAL ATTACHMENT
• Type of Device: DISPOSABLE DISTAL ATTACHMENT
• 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: 18758434
• MDR Text Key: 336001568
• Report Number: 9614641-2024-00449
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K984358
• 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: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D-201-13404
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/13/2024
• 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
• Treatment: PCF-H290ZI/UNKNOWN SERIAL NO.
• Patient Outcome(s): Required Intervention