MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF UNIT "ESG-400"; HF-GENERATORS

Model Number WB91051W

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

Patient Problem Stenosis (2263)

Event Date 01/30/2019

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.

Event Description

Olympus was informed that during a follow-up appointment after a successfully completed therapeutic transurethral resection of the prostate (turp) procedure, the patient suffered from pain and it was found that he had developed a bladder neck stenosis and urethral stricture.No further information was provided but there were no reports of any device malfunctions during the initial procedure.

Manufacturer Narrative

The esg-400 electrosurgical generator was not returned to the manufacturer for evaluation/investigation since there was no malfunction and the device is still being used by the user facility.However, it was reported that the esg-400 electrosurgical generator was inspected and tested at the user facility by a field service technician and found to be functioning correctly.It is assumed that the reported injuries were caused by fault currents, which penetrated tissue outside the desired area.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 without showing any abnormalities.Therefore, this event/incident was attributed to use error.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.In addition, the user will be informed about the investigation results.

• Brand Name: HF UNIT "ESG-400"
• Type of Device: HF-GENERATORS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 8304148
• MDR Text Key: 134966856
• Report Number: 9610773-2019-00049
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04042761076838
• UDI-Public: 04042761076838
• Combination Product (y/n): N
• PMA/PMN Number: K141225
• 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: 03/11/2020

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: WB91051W
• Device Catalogue Number: WB91051W
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/30/2019
• Initial Date FDA Received: 02/05/2019
• Supplement Dates Manufacturer Received: 02/28/2020
• Supplement Dates FDA Received: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention