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

Model Number	SD-210U-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001); Stenosis (2263); Pancreatitis (4481); Unspecified Hepatic or Biliary Problem (4493); Cholangitis (4821)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned.Attempts were performed to obtain additional information, but no response was received.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
Olympus reviewed the following literature titled "vws02-3 treatment outcomes of endoscopic papillectomy for duodenal papilla cancer".Literature summary [background] there is no consensus on the indications for endoscopic papillectomy (ep) for duodenal papilla cancer.[objective] to investigate the safety and prognosis of ep for duodenal papilla cancer.[method] among 77 cases of papilla tumors who underwent ep between may 2002 and october 2023, 33 cases (4 tis, 25 t1a (m), 2 t1a (od), and 2 t1b (du)) with a final pathological diagnosis of adenocarcinoma were included.We compared the en bloc resection rate, pathological complete resection rate, adverse events, recurrence rate, and recurrence pattern with 44 adenoma cases from the same period as controls.[results] the en bloc resection rate and pathological complete resection rate were 94% (31/33) and 42% (14/33) for adenocarcinoma and 89% (39/44) and 52% (23/44) for adenoma (p=0.69, 0.49, respectively).Early adverse events were observed in 30% (10/33) of adenocarcinoma patients (7 cases of bleeding, 4 cases of pancreatitis, 4 cases of perforation, 1 case of cholangitis) and 36% (16/44) of adenoma patients (10 cases of bleeding, 4 cases of pancreatitis, 3 cases of cholangitis, 2 cases of cholecystitis, 2 cases of perforation) (p=0.63).After ep, surgery was performed in 1 case of t1a (m) and 1 case of t1b (du), and chemotherapy was performed in 1 case of t1b (du).The mean observation period after ep was 1668 days for adenocarcinoma and 1708 days for adenoma.Late adverse events were observed in 15% (5/33) of adenocarcinoma patients (4 cases of bile duct stones, 1 case of duodenal stenosis) and 16% (7/44) of adenoma patients (4 cases of bile duct stones, 1 case of bile duct orifice stenosis, 1 case of pancreatic duct orifice stenosis) (p=1.00).The recurrence rates were 12% (3/26, 1 tis, 1 t1a(m), 1 t1a(od)) and 19% (7/36) for adenocarcinoma and adenoma, respectively (p=0.50).The recurrence rates in pathologically complete resection cases were 0% for adenocarcinoma and 11% (2/18) for adenoma, and 20% (3/15) for adenocarcinoma and 28% (5/18) for incomplete resection cases.The recurrence patterns were local recurrence in all adenoma cases and 1 tis case, while 1 t1a(m) case and 1 t1a(od) case were distant metastasis recurrence.All 8 cases of local recurrence were treated with apc ablation, and tumor control was achieved in 7 cases (6 adenomas, 1 tis), but 1 adenoma case experienced repeated local recurrences and was eventually diagnosed as adenocarcinoma by biopsy.The 2 cases of distant metastasis recurrence were treated with chemotherapy, but died of their original disease.[conclusion] there were no differences in the en bloc resection rate, pathological complete resection rate, or adverse events between adenoma and adenocarcinoma.When pathological complete resection is obtained, the recurrence rate is low even for adenocarcinoma, as long as the stage is t1a(m), and ep is considered to be a reasonable treatment.Type of adverse events/number of patients event1: bleeding (17) event2: pancreatitis (9) event3: cholangitis (16) event4: perforation (6) event5: cholecystitis (2) event6: duodenal stenosis (1) event7: choledochiarctia (1) event8: pancreatic duct stenosis (1).
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, 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.This supplemental report includes a correction to h8 to provide information that was inadvertently not included in the initial medwatch.Olympus will continue to monitor field performance for this device.

• Brand Name: DISPOSABLE ELECTROSURGICAL SNARE
• Common Device Name: 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: 19619967
• Report Number: 9614641-2024-01334
• Device Sequence Number: 15475084
• Product Code: FDI
• UDI-Device Identifier: 04953170298424
• UDI-Public: 04953170298424
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K902735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2024

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-210U-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: 05/30/2024
• Supplement Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Sex: Unknown