MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ELECTROSURGICAL SNARE SD-400

Model Number	SD-400U-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the literature described "snaremaster", olympus used sd-400u-15 as a representative product.The suspect device referenced in this report has not been returned to olympus.Additional information has been requested but no information has been provided at this time.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is received.
Event or Problem Description
Olympus medical systems corp.(omsc) received a literature titled "can underwater endoscopic mucosal resection be an alternative to conventional endoscopic mucosal resection for superficial non-ampullary duodenal epithelial tumors?" literature summary objectives: underwater endoscopic mucosal resection (uemr) is a simpler procedure for superficial non-ampullary duodenal epithelial tumors (snadet) than conventional endoscopic mucosal resection (cemr).This study aimed to evaluate whether cemr can be substituted by uemr for snadet in terms of effectiveness, safety, and learning curve.Methods: a total of 157 consecutive patients with 203 snadets <20 mm in diameter, including 107 lesions resected by cemr and 96 lesions resected by uemr, between january 2019 and may 2023, were retrospectively recruited.The treatment outcomes were compared between the cemr and uemr groups.The risk factors for incomplete resection by uemr were analyzed using univariate and multivariate analyses.Lesions in the uemr group were divided chronologically into five periods; thereafter, the en bloc resection rate and procedure time were compared.Results: no significant differences existed between the cemr and uemr groups in the mean procedure time (3.9 min vs.3.6 min, p = 0.1380) or en bloc resection rate (91% vs.94%, p = 0.4138).No perforation was observed in either group.Tumor size was an independent risk factor for incomplete resection using uemr (p < 0.01).The history of biopsy was not associated with incomplete resection using uemr.The en bloc resection rate of uemr was 100% (20/20) in the first period and ranged from 90% to 100% over all periods.Postoperative bleeding was observed in one case in the uemr group, in which endoscopic hemostasis was achieved without blood transfusion.Conclusion: uemr is safe and effective for snadet <20 mm, regardless of a history of biopsy, and is easy to learn.Thus, uemr can serve as an alternative to cemr.The following events have been reported in the literature.Event1: postoperative bleeding requiring endoscopic hemostasis (n=1) this literature article requires 5 reports.The related patient identifiers are as follows: (1) (b)(6)- gif-q260j (2) (b)(6) - gif-h290t (3) (b)(6) - pcf-h290ti (4) (b)(6) - sd-400u-15 (5) (b)(6) - hx-610-090l this medwatch report is for (b)(6).There is no report of any olympus device malfunction in any procedure described in this study.
Additional 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.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE ELECTROSURGICAL SNARE SD-400
• Common Device Name: 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: 18335745
• Report Number: 9614641-2023-01916
• Device Sequence Number: 20511389
• Product Code: FDI
• UDI-Device Identifier: 04953170408250
• UDI-Public: 04953170408250
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SD-400U-15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2023
• Supplement Date Received by Manufacturer: 12/27/2023
• Initial Report FDA Received Date: 12/15/2023
• Supplement Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown