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

Model Number WB91051W

Device Problems Defective Component (2292); Output Problem (3005)

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

Event Date 06/07/2023

Event Type  malfunction  

Manufacturer Narrative

The device evaluation was unable to confirm the customer¿s reported problem of loosing energy.However, an e433 error occurred due to a defective high voltage power supply board.The evaluation also noted a cracked front panel at the bottom right corner.The recorded fault log found multiple errors of e433, e006, e486 and e187.No further information regarding the event was provided by the customer.The dhr showed that the device was manufactured according to valid instructions and met all specifications.The investigation is still in progress; however, if additional information becomes available, this report will be supplemented accordingly.

Event Description

The customer reported that during procedure, the high frequency electrosurgical generator was ¿losing energy¿.The device was returned for service and during the evaluation, the following reportable malfunction was identified: an e433 error due to a defective hvps board.The registered nurse at the user facility further reported the therapeutic robotic assisted bio-prostatectomy was completed with the same device without delay.The staff that performed the procedure stated the error code flashed on and off quickly and were unable to capture the exact code.No death or injury and no impact to patient or other has been reported.

• Brand Name: HF UNIT "ESG-400"
• Type of Device: ELECTROSURGICAL GENERATOR ESG-400
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17264044
• MDR Text Key: 318451959
• Report Number: 9610773-2023-01805
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WB91051W
• Device Catalogue Number: WB91051W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2016
• 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