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

Model Number WB991036

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

Patient Problems Fistula (1862); Hemorrhage/Bleeding (1888)

Event Date 07/26/2022

Event Type  Injury  

Manufacturer Narrative

The suspect medical device was not returned to the manufacturer for investigation/evaluation.Therefore, the manufacturer's evaluation was exclusively performed on the basis of the provided information.There is no report of device malfunction.We are unable to determine if the hf-generator caused or contributed to the reported adverse events.Since no product malfunction was reported and no device was returned, the affected device very likely meets the standard specifications.The exact cause of the reported phenomena and the patients' outcome could not be determined and is being judged as unknown.Furthermore, a manufacturing and quality control review could not be performed since basic data of article identification (serial number) are missing.The case will be closed from olympus side with no further actions but the reported event/incident will be recorded for trending and surveillance purposes.

Event Description

Olympus was informed through a study that 72 hours after a endoscopic retrograde cholangiopancreatography (ercp) procedure a patient suffered bleeding and choledochal-duodenal fistula which was treated with a plastic stand.Post-ercp pancreatitis and cholangitis occurred in less than 5% of patients, with only one case of post-ercp cholangitis in the study group.There were no other post-ercp bleeding or perforations detected.There was no report about a malfunction of a medical device.

• Brand Name: OLYMPUS ESG-100, 220...240 V~,
• Type of Device: HF-GENERATORS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; rheinstrasse 8; teltow 14513 ; GM 14513
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662
• MDR Report Key: 15248033
• MDR Text Key: 298115114
• Report Number: 9610773-2022-00334
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04042768910364
• UDI-Public: 04042768910364
• Combination Product (y/n): N
• Reporter Country Code: RO
• PMA/PMN Number: K073207
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/29/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention