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

Model Number SD-210U-15

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/24/2022

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report was not returned to olympus for evaluation.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

It is reported in the literature titled "a case of lump-sum resection of a duodenal papillary tumor with lateral extension by ep with hybrid esd" a patient experienced a posterior hemorrhage requiring endoscopic hemostasis.Patient/background/procedure: a male in his 60s underwent a total colorectal resection at the age of 42 by his previous physician due to a history of familial adenomatous polyposis (fap) and had been followed up regularly since then.He was referred to our department for close examination and treatment after multiple duodenal tumors were detected during egd at his previous doctor.Egd showed a duodenal papillary tumor of less than 30 mm in diameter with white opaque substance (wos).After close examination by endoscopic ultrasound (eus) and endoscopic retrograde cholangiopancreatography (ercp), a diagnosis of duodenal papillary adenoma without extension into the pancreaticobiliary duct was made.Since the papillary tumor had lateral extension to the anorectal side, it was considered difficult to secure negative margins by conventional endoscopic papillary resection (ep).We planned to perform an en bloc resection by ep with hybrid esd, in which the tumor is resected by snare after esd incision and dissection around the tumor.After incision and dissection of 4/5 circumference of the anal side of the papillary tumor with flushknife (fujifilm) while using direct ophthalmoscopy with submucosal localization, the patient was transferred to ep with a lateral ophthalmoscope.The tumor was snared and resected with a snaremaster (olympus), including the anorectal edge, in line with the esd incision line.Hemostasis was performed with hemostatic forceps for bleeding from the resection surface, and enpbd was placed to prevent exposure to pancreatic juice and bile, and the procedure was terminated.Endoscopic hemostasis was required for posterior hemorrhage, but the patient remained stable and was discharged 10 days after surgery.Histopathology revealed a 31 x 23 mm resection specimen, a 28 x 20 mm lesion, tubular adenoma, negative vertical margins, and negative horizontal margins.Discussion: when resecting duodenal papillary tumors with ep, it is desirable to resect the tumor en bloc without leaving any residual tumor.However, because the extent of ep resection is defined by the snare used, it can sometimes be difficult to ensure negative margins.In the present case, a duodenal papillary tumor that was considered difficult to resect en bloc by conventional ep snaring was successfully resected en bloc by using hybrid esd combined with incision and dissection.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The dhr was unable to be reviewed for this device since the serial 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 reporter confirmed there was no malfunction in the olympus product therefore it is considered that this event was not caused by the defect of the product.A definitive root cause cannot be identified.Olympus will continue to monitor the field performance of 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: 15844346
• MDR Text Key: 304117812
• Report Number: 9614641-2022-00654
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 04953170298424
• UDI-Public: 04953170298424
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SD-210U-15
• 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: 12/19/2022
• 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): Other; Required Intervention
• Patient Sex: Male