MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. DISPOSABLE ELECTROSURGICAL SNARE

Model Number SD-210U-25

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/26/2022

Event Type  Injury  

Event Description

Olympus corporation received a literature titled "underwater versus conventional emr for nonpedunculated colorectal lesions: a randomized clinical trial".Background and aims: conventional endoscopic mucosal resection (cemr) is the standard modality for removing nonpedunculated colorectal lesions.Underwater endoscopic mucosal resection (uemr) has emerged as an alternative method.There are few comparative studies between these techniques, especially evaluating recurrence.Therefore, the purpose of this trial was to compare cemr and uemr for the resection of colorectal lesions with respect to efficacy, safety, and recurrence rate.Methods: this was a randomized controlled trial of uemr versus cemr for naïve and nonpedunculated lesions measuring between 10 and 40 mm.The primary outcome was adenoma recurrence at 6 months after the resection.Secondary outcomes were rates of technical success, en bloc resection, and adverse events.Block randomization was used to assign patients.Tattooing was performed to facilitate localization of the scars and eventual recurrences.Endoscopic follow-up was scheduled at 6 months after the procedure.The sites of resections were examined with white-light imaging, narrow-band imaging (nbi), and conventional chromoscopy with indigo carmine followed by biopsies.Results: one hundred five patients with 120 lesions were included, with a mean size of 17.5 ± 7.1 (sd) mm.Sixty-one lesions were resected by uemr and 59 by cemr.The groups were similar at baseline regarding age, sex, average size, and histologic type.Lesions in the proximal colon in the cemr group corresponded to 83% and in the uemr group to 67.8% (p =.073).There was no difference between groups regarding success rate (1 failure in each group) and en bloc resection rate (60.6% uemr vs 54.2% cemr, p =.48).Intraprocedural bleeding was observed in 5 cemrs (8.5%) and 2 uemrs (3.3%) (p =.27).There was no perforation or delayed hemorrhage in either group.Recurrence rate was higher in the cemr arm (15%) than in the uemr arm (2%) (p =.031).Therefore, the relative risk of 6-month recurrence rate in the cemr group was 7.5-fold higher (95% ci, 0.98-58.20), with a number needed to treat of 7.7 (95% ci, 40.33-4.22).The higher recurrence rate in the cemr group persisted only for lesions measuring 21 to 40 mm (35.7% vs 0%; p =.04).Conclusion: this study demonstrated that uemr was associated with a lower adenoma recurrence rate than was cemr.Both endoscopic techniques were effective and had similar rates of adverse events for the treatment of nonpedunculated colorectal lesions from april 2017 to march 2021, 105 patients with 120 lesions were enrolled.Seven patients were excluded: 2 had lesions with clear signs of submucosal invasion, 4 had life expectancy <6 months (2 because of advanced oncologic disease and 2 because of severe cardiopulmonary comorbidities), and 1 declined to participate.

Manufacturer Narrative

The literature described 25-mm snare master used in the literature, olympus selected sd-210u-25 as the representative model.The report is related to the following linked patient identifiers- (b)(6).Once the investigation has been completed, a supplemental report will be submitted with the device evaluation results.

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

• Brand Name: DISPOSABLE ELECTROSURGICAL SNARE
• Type of Device: DISPOSABLE ELECTROSURGICAL SNARE
• 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: 18833706
• MDR Text Key: 336854409
• Report Number: 9614641-2024-00561
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 04953170037009
• UDI-Public: 04953170037009
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K902735
• 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: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SD-210U-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/26/2024
• 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: COLONOVIDEOSCOPE CF-H180AL, SN-UNK.; COLONOVIDEOSCOPE, CF-H190L, SN-UNK.; IRRIGATION PUMP (OFP-2), SN-UNK.
• Patient Outcome(s): Required Intervention