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 Problem Bowel Perforation (2668)

Event Date 11/05/2019

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.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 colonoscopy with polypectomy procedure, the patient may have sustained a bowel perforation in the area of the hepatic angle.Several hours after the colonoscopy with polypectomy procedure of two sessile polyps had been performed, the patient returned to the emergency department of the hospital due to abdominal pain.No further information was provided.

Manufacturer Narrative

The suspect medical device was not returned to olympus for evaluation/investigation.Therefore, the investigation/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, the instructions for use contain several warning notes referring to possible risks and complications when using the hf generator.For example, mechanical stress at the treatment site when using a snare can result in bleeding and perforation to the patient.This may happen, for example, if the snare is closed for cutting before the hf current is activated.Also, inappropriate output of power can result in bleeding, perforation and burns to the patient.Based on the information available, it must be assumed that the reported event/incident was most likely caused by use error.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.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.

• 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: 9314581
• MDR Text Key: 166131608
• Report Number: 9610773-2019-00160
• 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
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• 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: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED 10 MM POLYPECTOMY LOOP; UNSPECIFIED 10 MM POLYPECTOMY LOOP
• Patient Outcome(s): Hospitalization