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

Model Number WB91051W

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Burning Sensation (2146); Fluid Discharge (2686); Urethral Stenosis/Stricture (4501)

Event Date 09/25/2023

Event Type  Injury  

Event Description

A customer reported to olympus that after a transurethral resection of the prostate, the patient complained about "internal infection or something like burn" four days post procedure.It was originally stated that the physician "checked" and found an injury at the internal urethra with sebum or pus.No intervention other than a dressing was required.Additional information indicated that the physician performed a cystoscopy as a diagnostic tool for pain at the follow up appointment.It was interpreted that a stricture was the cause of the issue.No other intervention was required and the patient was stated to be fine.

Manufacturer Narrative

Upon inspection of the returned device, there were no functional issues found.All safety parameters (output power and high frequency leakage currents) were found to be within specification.Other functions were also working as intended.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

• 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, hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18554011
• MDR Text Key: 333381939
• Report Number: 9610773-2024-00221
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04042761076838
• UDI-Public: 04042761076838
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Report Date: 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2024
• 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: 01/31/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2014
• 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: CYSTOSCOPE - SN (B)(6)
• Patient Outcome(s): Required Intervention
• Patient Sex: Male