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

Model Number WB91051W

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Type  Injury  

Event Description

The physician reported to olympus that the hf unit "esg-400" did not perform to specification and cutting into the tissue during an unknown therapeutic procedure was not possible.After attempts to change parameters and different loop options, the results remained the same that the tissue was unable to be resected.The intended procedure was not completed and has not been rescheduled.No medical interventions were reported to be required due to the reported event.It is unknown if the patient will have a follow-up post operative appointment to determine if cancerous tissues were left inside the patient body.Additional follow-up for patient's current condition, procedural details and outcome of the procedure were requested but not available at the time of the report.

Manufacturer Narrative

The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

H10 : this supplemental report is being submitted to provide corrected data/information regarding the reported event.A correction was added to b5.

Event Description

Additional information received that this complaint is a duplicate of complaint (b)(4) and the initial complaint (b)(4) was reported was filed in error.The ongoing information and investigation activities will be reported under complaint (b)(4).

• 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; kuehnstrasse 61; hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18341217
• MDR Text Key: 330663843
• Report Number: 9610773-2023-03651
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04042761076838
• UDI-Public: 04042761076838
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WB91051W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/27/2021
• 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
• Patient Outcome(s): Other