MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. DISPOSABLE ELECTROSURGICAL SNARE

Model Number	SD-221L-25
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001)
Date of Event	12/01/2021
Type of Reportable Event	Serious Injury
Additional 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 receipt of additional relevant information.
Event or Problem Description
It is reported in the literature titled "study of 109 cases by endoscopic treatment (anti-reflux mucosectomy: arms) for acid secretion inhibitor (ppi) resistant refractory gastroesophageal reflux disease (gerd) (with video) ", three patients experienced adverse effects during or after an endo-reflux mucosectomy (arms) using a disposable electrosurgical snare.Study aim: investigate the efficacy of arms in patients with ppi refractory gerd.Method: retrospective review of 109 patients with ppi refractory gerd who underwent arms and compared the questionnaire scores, acid-exposure times, number of demeester score, proximal reflux, and ppi discontinuation rates before and after arms.Results: subjective symptoms were significantly improved (p<0.01) and ppi could be discontinued in 40-50% of the patients after arms.In addition, improvement in subjective symptoms was maintained in the 3-year follow-up patients.Acid-exposure time or demeester score improved after arms (p<0.01), but proximal reflux did not improve significantly (p=0.0846).Conclusion: arms is a valuable minimally invasive treatment for people with ppi refractory gerd.The effectiveness of treatment is due to inhibition of acid reflux by scar formation in the cardia.Two postoperative bleeding events occurred in patients.These patients were treated with endoscopic hemostasis without the use of blood transfusions.Minor perforation was observed in one patient.This patient was treated with endoscopic clip closure of the defect.No additional consequences to the patients were reported.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 and from the author.The device history record was unable to be reviewed for this device since the 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.Olympus will continue to monitor field performance for this device.
Event or Problem Description
Additional information was received from the author: in the medical opinion of the author, the olympus devices did not cause or contribute to the adverse events.The author stated: from the content raised (reported), it is presumed that it was not caused by a defect in the product, but the cause could not be identified.

• Brand Name: DISPOSABLE ELECTROSURGICAL SNARE
• Common Device Name: DISPOSABLE ELECTROSURGICAL SNARE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13498125
• Report Number: 8010047-2022-02670
• Device Sequence Number: 17172297
• Product Code: FDS
• UDI-Device Identifier: 04953170326356
• UDI-Public: 04953170326356
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K955650
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2022

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-221L-25
• 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: 01/12/2022
• Supplement Date Received by Manufacturer: 06/10/2022
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 07/06/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Q260J, MAJ-296
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown