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 Date 05/09/2023

Event Type  Injury  

Manufacturer Narrative

The suspect device has not been returned to olympus.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is received.

Event Description

The customer reported to olympus that during a therapeutic gynecological procedure, removal of the uterus, using an hf unit "esg-400" with the pk cutting forceps, 5mm, 33cm, the devices did not function as desired.Consequently, the procedure was converted to an open surgery, which was completed without complications.The patient was reportedly fine.The esg and cutting tool were checked prior to the procedure and no issues were noted.It also worked fine the following day when it was checked.The gas was also checked outside the patient.The esg will be checked by a field service inspector, and an olympus representative will observe for the next procedure and have additional replacement tools.Case with patient identifier (b)(6) reports the hf unit "esg-400".Case with patient identifier (b)(6) reports the pk cutting forceps, 5mm, 33cm.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and evaluation with correction to the initial with information inadvertently left out.Additionally, to provide updates to fields (d9 and h3).The subject device was not sent back to olympus.However, the subject device was inspected onsite and the defect was not confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the cause for the reported issue remains unclear.Since no malfunction of the generator is identified, it is likely that the reported issue might be traced back to a user error.The reported medical incident (conversion to open surgery) is not related to the identified technical issues.The root cause of the reported issue could not be determined.Olympus will continue to monitor field performance for this device.

• 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: 17101132
• MDR Text Key: 316946856
• Report Number: 9610773-2023-01609
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04042761076838
• UDI-Public: 04042761076838
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K203682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WB91051W
• Device Catalogue Number: WB91051W
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2016
• 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
• Treatment: PK-CF0533 / LOT NUMBER 261738.
• Patient Outcome(s): Other