MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH ELECTROSURGICAL GENERATOR ESG-150; HF-GENERATORS

Model Number WA90150W

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

Patient Problems Abdominal Pain (1685); Bowel Perforation (2668)

Event Date 03/30/2021

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.

Event Description

Olympus was informed that a few hours after having been discharged from the hospital after a therapeutic polypectomy procedure in the cecum where a polyp of about 1.5 cm was removed, the patient felt pain and returned to the hospital.An intestinal perforation was detected and an emergency surgery was performed where a part of the colon was removed.There were no reports of any malfunction of any of the olympus devices used during the initial procedure.No further information was provided.

Manufacturer Narrative

The suspect medical device was not returned to the manufacturer for evaluation/investigation but to the olympus cz regional repair center (returned to the repair center on 2021-04-14).The evaluation at the repair center 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 most likely 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-150
• Type of Device: HF-GENERATORS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 11654703
• MDR Text Key: 245432122
• Report Number: 9610773-2021-00114
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04042761085793
• UDI-Public: 04042761085793
• Combination Product (y/n): N
• PMA/PMN Number: K182587
• 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: 04/27/2021

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: WA90150W
• Device Catalogue Number: WA90150W
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/06/2021
• Initial Date FDA Received: 04/13/2021
• Supplement Dates Manufacturer Received: 04/27/2021
• Supplement Dates FDA Received: 04/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS INJECTION NEEDLE NM-400U-0523; OLYMPUS POLYPECTOMY SNARE SD-210U-25
• Patient Outcome(s): Hospitalization; Required Intervention