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

Model Number WA90003W

Device Problem Output Problem (3005)

Patient Problem Blood Loss (2597)

Event Date 02/04/2021

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: (b)(4).

Event Description

Olympus was informed that during a therapeutic mucosecotomy procedure at an unknown date, the surgeon felt that the coagulation performance was poor when cutting tissue.This resulted in clotting problems and difficulty to stop the bleeding.No further information was provided.

Event Description

Olympus was informed that during a therapeutic mucosectomy procedure, the surgeon felt that the coagulation performance was poor when cutting tissue.This resulted in clotting problems and difficulty to stop the bleeding.This phenomenon was resolved by using coagulation forceps and the application of ¿purastat¿.This intervention resulted in a prolongation of procedure time of about 60 minutes.The patient was hospitalized as a precautionary measure for a couple of days during which the patient's state of health was reported to be good.

Manufacturer Narrative

The suspect medical device was not returned to the manufacturer for evaluation/investigation but to an olympus regional repair center (rrc) in italy (returned to the rrc on 2021-04-05).The evaluation at the rrc did not reveal any malfunctions of the hf-generator but found the device to be working correctly.No abnormality, defect, failure or malfunction could be determined.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 hf generator without showing any abnormalities.Based on the information available, the exact cause of the reported phenomenon and the patient¿s outcome could not be conclusively determined.However, since the generator was evaluated as in standard, this event/incident can in all likelihood be attributed to use error.The case will be closed on olympus side with no further actions.The reported event/incident will be recorded for trending and surveillance purposes and 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: 11320428
• MDR Text Key: 234955672
• Report Number: 9610773-2021-00074
• 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: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• 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
• Date Manufacturer Received: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention