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

Model Number WA90003W

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

Patient Problems Hemorrhage/Bleeding (1888); Blood Loss (2597)

Event Date 09/18/2020

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"; common device name: hf-generators; 510(k): k180200; product code: gei.

Event Description

Olympus was informed that during a therapeutic polypectomy procedure, sudden and significant bleeding occurred as a result of which, the patient was transferred to intensive care unit for observation and transfusion.The intended procedure was completed with an intervention procedure and the patient is reported to be recovering well.

Manufacturer Narrative

Device evaluation: the suspect medical device was not returned to the manufacturer for investigation but to an olympus regional repair center in the united kingdom.During the evaluation/investigation the affected device did not show any malfunctions which might have caused the patient¿s outcome.Therefore, the exact cause of the reported phenomenon could not be determined and is being judged as unknown.In addition, a detached foot switch socket and cracks on the front panel were detected.The cause for the detached foot switch socket remains unclear while the cause for the cracked front panel is very likely improper handling.Furthermore, a material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected serial number of the electrosurgical generator "esg-300" without showing any abnormalities.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.Furthermore, the user will be informed about the investigation results.

• Brand Name: ELECTROSURGICAL GENERATOR "ESG-300"
• Type of Device: HF-GENERATORS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 10606280
• MDR Text Key: 209162634
• Report Number: 9610773-2020-00230
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/25/2020
• Initial Date FDA Received: 09/30/2020
• Supplement Dates Manufacturer Received: 10/15/2020; 11/25/2020
• Supplement Dates FDA Received: 10/16/2020; 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED DIATHERMY SNARE; UNSPECIFIED DIATHERMY SNARE
• Patient Outcome(s): Hospitalization; Required Intervention