MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH ELECTROSURGICAL GENERATOR "ESG-300"; HF-GENERATORS

Model Number WA90003J

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

Patient Problem Bowel Perforation (2668)

Event Date 03/06/2020

Event Type  Injury  

Manufacturer Narrative

The suspect medical device was not returned to olympus for evaluation/investigation.Therefore, the evaluation was performed exclusively on the basis of the information provided by the customer.There were no reports of any malfunction of the generator.Based on the information available, the exact cause of the reported phenomenon and the patient¿s outcome could not be determined and is being judged as unknown.However, a material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected serial number of the hf generator without showing any abnormalities.The case will be closed on olympus side with no further actions.The reported event/incident will be recorded for trending and surveillance purposes.Furthermore, the user will be informed about the investigation results.Please note: this report is being submitted although the suspect medical device is not marketed in the usa.However, a similar device is marketed.Model # / catalog #: wa90300w; brand name: electrosurgical generator "esg-300"; common device name: hf-generators; 510(k): k180200; product code: gei.

Event Description

Olympus was informed that during a therapeutic endoscopic submucosal dissection (esd) in the colon procedure, the patient sustained a perforation of the colon.The intended procedure was cancelled and converted to open surgery.No further information was provided, but there was no report about a malfunction of the olympus medical devices.Also, it was reported that the patient had weak tissue due to steroid medication.

• Brand Name: ELECTROSURGICAL GENERATOR "ESG-300"
• Type of Device: HF-GENERATORS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 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: 9848232
• MDR Text Key: 192160543
• Report Number: 9610773-2020-00094
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WA90003J
• Device Catalogue Number: WA90003J
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2019
• 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): Required Intervention
• Patient Age: 75 YR