MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH OLYMPUS ESG-100, 220...240 V~,; ELECTROSURGICAL UNITS

Model Number WB991036

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

Patient Problem Unspecified Hepatic or Biliary Problem (4493)

Event Type  Injury  

Manufacturer Narrative

This report is being submitted report adverse events and to provide investigation results.No physical evaluation/inspection could be conducted on the suspect device as it was not returned to olympus.The device history record (dhr) for the complaint device could not be reviewed since the serial number was not provided.Olympus did a dhr review of the past 24 months and found no non-conformities related to the reported event.Olympus does not ship any device that does not meet all design and safety specifications.There was no report of olympus device malfunction and no information connecting the cause of the reported events to the device.For these reasons, the definitive cause of the reported events could not be determined.

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.

• Brand Name: OLYMPUS ESG-100, 220...240 V~,
• Type of Device: ELECTROSURGICAL UNITS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662
• MDR Report Key: 13790537
• MDR Text Key: 292500038
• Report Number: 9610773-2022-00101
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04042768910364
• UDI-Public: 04042768910364
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K073207
• 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
• Report Date: 03/16/2022

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: WB991036
• Device Catalogue Number: WB991036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other