MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS

Model Number	FD-410LR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994); Melena (4480)
Date of Event	02/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus reviewed the following literature titled "evaluation of antireflux mucosectomy for severe gastroesophageal reflux disease: medium-term results of a pilot study".The aim of our study was to evaluate the medium-term efficacy of the antireflux mucosectomy (arms) technique for patients with severe gastroesophageal reflux disease (gerd) symptoms (proton pump inhibitors (ppi)-treatment-dependent or ppi treatment-resistant gerd).A total of 13 patients were included.After 24 months arms, gerd symptoms were significantly improved for the 11 remaining patients, for whom median gerd-hrql score decreased from 33 (iqr 26-42) to 3 (iqr 0-7) (p = 0:001).Heartburn, regurgitation and dysphagia had disappeared for all the patients at 24 months.Despite these short-term adverse events, the overall patient satisfaction in reducing gerd symptoms was very good, 9/11 patients (81%) were willing to repeat arms if needed.In this pilot study, arms of esophagogastric junction (egj) was a feasible and effective medium-term technique for gerd treatment with a relatively high morbidity rate.Type of adverse events/number of patients: intraoperative bleeding - 13 patients.*13 patients had intraoperative bleeding and the following complications, respectively.Melena - 1 patient, melena & pain - 1 patient, immediate or postoperative thoracic or abdominal pain - 7 patients, intermittent pain - 1 patient, egj stenosis - 1 patient.This literature article requires 2 reports.The related patient identifiers are as follows: (b)(6).This medwatch report is for patient identifier (b)(6).There is no report of any olympus device malfunction in any procedure described in this study.
Additional Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation.The investigation is in process.The literature article doi: https://doi.Org/10.1155/2022/1606944 provided for additional information.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
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 events 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 HEMOSTATIC FORCEPS
• Common Device Name: SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS
• 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: 16895068
• Report Number: 9614641-2023-00636
• Device Sequence Number: 12251179
• Product Code: KNS
• UDI-Device Identifier: 04953170208430
• UDI-Public: 04953170208430
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K062517
• 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): 05/18/2023

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: FD-410LR
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2023
• Supplement Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 05/18/2023
• 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; Other
• Patient Sex: Unknown