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

Model Number WB91051W

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/16/2024

Event Type  malfunction  

Manufacturer Narrative

The olympus field service engineer (fse) visited the facility to help troubleshoot the problem but could not repeat the issue.The fse suggested that the facility inspects the connection between the loop and cable before use.The device was not returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

It was reported, that while using the electrosurgical generator esg-400, the unit experienced an e006 error.The issue occurred during a transurethral resection procedure.The unit was changed to continue the case until finish and there was no effect on the patient and no reports of patient harm.

• Brand Name: HF UNIT "ESG-400"
• Type of Device: ELECTROSURGICAL GENERATOR ESG-400
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrase 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18640369
• MDR Text Key: 334544778
• Report Number: 9610773-2024-00335
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K203682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WB91051W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1