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

Model Number WA90003W

Device Problem Insufficient Information (3190)

Patient Problem Perforation (2001)

Event Type  Injury  

Manufacturer Narrative

The suspect medical device has not yet been returned to olympus for evaluation/investigation.Therefore, the exact cause of the patient's outcome and the reported phenomenon could not be determined and is being judged as unknown.However, if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.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" with foot switch; common device name: hf-generators; 510(k): k180200; product code: gei.

Event Description

Olympus was informed that during an unspecified therapeutic procedure at an unknown date, the mucosa of the patient was perforated due to faulty coagulation function.The procedure was modified to be able to complete it.No further information was provided, and the patient¿s current condition is also unknown.

Manufacturer Narrative

Additional information: b5 - describe event or problem.Correction: h4 - device manufacturer date.Device evaluation: the suspect medical device was not returned to the manufacturer for investigation/evaluation.Instead an olympus field service engineer (fse) was on site to check the device.During the inspection the fse confirmed that the hf-generator is in standard condition.Furthermore, there were no reports of any malfunction of the hf 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, unintended use error is likely.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.

Event Description

Olympus was informed that during a therapeutic mucosectomy procedure at an unknown date, the mucosa of the patient was perforated due to faulty coagulation function.The procedure was modified to be able to complete it and the surgeon clipped instead.However, the patient is doing well by now.

• 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; hamburg
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662
• MDR Report Key: 15127989
• MDR Text Key: 296846792
• Report Number: 9610773-2022-00306
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WA90003W
• Device Catalogue Number: WA90003W
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2019
• 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