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

Model Number SD-210U-15

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

Patient Problem Unspecified Hepatic or Biliary Problem (4493)

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.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 ¿single-duct stenting and est-additional procedures after endoscopic papillectomy: bile duct stenting and/or endoscopic sphincterotomy,¿ a patient experienced cholangitis after a procedure using olympus devices.Case with patient identifier (b)(6) will report the tjf-260v used in the procedures.Case with patient identifier (b)(6) will report the sd-210u-15 used in the procedures.Case with patient identifier (b)(6) will report the olympus esg-100 used in the procedures.Introduction/ study aim: endoscopic papillectomy (endoscopic papillectomy: ep) is becoming a widespread resection technique for duodenal papilloma.One of the most minimally invasive but risky endoscopic procedures compared to surgical treatment, and prevention of accidental disease is important.Since ep was first reported in japan, it will be about 40 years, but the procedure has not yet been established, and the positional of endoscopic bile duct stenting (bile duct stenting) and endoscopic sphincterotomy (est) at the time of ep, which is the topic of this article, is also unclear.In this article, based on previous reports, the roles of bile duct stenting and est after ep are outlined in terms of "preventive of accidental disease (cholangitis)" and "measures to be taken in the event of accidental disease." study method: retrospective review of previous study reports evaluating the role of bile duct stenting and est/ep in preventing accidental disease and measures taken to treat accidental disease.Results: ep was performed in 45 cases, of which 22 cases in the first term (2009-2017) were based on stenting of the bile duct and pancreatic duct, and 23 cases in the second term (2018-2021) were based on est to the bile duct orifice and pancreatic duct stenting.Acute cholangitis developed early postoperatively in 1 of 45 patients (2%).Treatment not specified.Conclusions: bile duct stenting and est after ep are outlined based on previous reports.Due to the lack of evidence, the decision to use a bile duct stent or est after ep is currently left to the judgment of each institution and surgeon, but it is important to evaluate the outflow of bile from the bile duct orifice after ep and respond appropriately.There was no report of olympus device malfunction in any procedure described in this literature.

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 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.

• Brand Name: DISPOSABLE ELECTROSURGICAL SNARE
• Type of Device: 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: 13790536
• MDR Text Key: 292495230
• Report Number: 8010047-2022-04520
• 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: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2022
• 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: 04/04/2022
• 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