MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF UNIT "ESG-400"; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number WB91051W

Device Problems Component Missing (2306); Electrical Power Problem (2925)

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

Event Type  malfunction  

Manufacturer Narrative

Additional evaluation findings by the olympus service center are provided below.The reported event of 'error needs service' was not confirmed.The plastic around the neutral port cracked from the front panel.The grounding cable is disconnected from the lvps board.Minor scratches on top cover, especially along back of unit.Errors e433 and e202 are recorded in the error log multiple times, but were not duplicated during inspection.The final investigation results from the legal manufacturer have been provided below.The investigation is based on the information provided by the customer and olympus service center findings.The dhr review showed the device was manufactured according to valid instructions and met all specifications.A manufacturing and quality control review was performed for device.There are no non-conformities associated with this device with respect to the described issues: e433 error and missing knob.There are no capas associated with this device with respect to the described issue.A definitive root cause of the issues were not identified.Based on the available information, the legal manufacturer determined the probable cause of the e433 error is likely due to the following non-intended use scenarios: metal-to-metal sparking, and simultaneous use of two hf surgical generators.It could also be caused by a faulty footswitch.Error e433 is triggered by the safety system of the esg-400 and results in a restart of the generator.There was an issue identified with the generator boards and error e433 and an improved generator board was introduced into production in mid-july 2020.Based on the available information, the legal manufacturer determined the probable cause of the missing knob is likely due to the user since it can easily go missing when removed by the user.In general, the customer is required to check the function of all devices used prior to a procedure.Additionally, according to the instructions for use, a suitable replacement device must be provided during an application.Investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.

Event Description

The customer reported to olympus the device had an unknown error when they prepared for an unknown procedure.In addition, the customer reported the foot switch cord was almost completely "ripped out" and the lip around the neutral port of the front panel was cracked/chipped.The subject device was not used in the procedure.The procedure was completed with an unknown device.The device was returned to the olympus service center for repair.The service center found error e433 in the device error log and a missing volume knob.This report is being submitted to capture the e433 error and missing volume knob, which are reportable events.No patient harm or injury was reported.

• Brand Name: HF UNIT "ESG-400"
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662
• MDR Report Key: 12309280
• MDR Text Key: 267307798
• Report Number: 9610773-2021-00222
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04042761076838
• UDI-Public: 04042761076838
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Device Lot Number: B001402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/16/2021
• Initial Date FDA Received: 08/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2016
• 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