MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH BERLIN FACILITY FOOT SWITCH, SINGLE, FOR, ESG-400; ELECTROSURGICAL GENERATOR

Model Number WB50403W

Device Problem Communication or Transmission Problem (2896)

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

Event Date 08/07/2023

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported that the high frequency electrosurgical generator unit had an error code e433 displayed.The event occurred during preparation for use.There was no patient harm associated with the event.For the esg-400 device, please see patient identifier (b)(6).This file captures the footswitch used in conjunction with the esg-400.

Manufacturer Narrative

This supplemental report is to inform that upon further review, this is not a reportable malfunction for the footswitch and was submitted in error.The initial medwatch reported the high frequency electrosurgical generator unit had an error code e433 displayed; however; this event has already been reported on medwatch 9610773-2023-02410 (patient identifier (b)(6)).Refer to this file for supplemental information related to this event.

• Brand Name: FOOT SWITCH, SINGLE, FOR, ESG-400
• Type of Device: ELECTROSURGICAL GENERATOR
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH BERLIN FACILITY; rheinstrasse 8; teltow, brandenburg 14513 ; GM 14513
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH BERLIN FACILITY; rheinstrasse 8; teltow, brandenburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17695682
• MDR Text Key: 322810248
• Report Number: 3003724334-2023-00033
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04042761076814
• UDI-Public: 04042761076814
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/25/2023

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: WB50403W
• Device Lot Number: 1934-2608
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/07/2023
• Initial Date FDA Received: 09/06/2023
• Supplement Dates Manufacturer Received: 09/25/2023
• Supplement Dates FDA Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: ESG-400