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

Model Number WB91051W

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

Patient Problem Internal Organ Perforation (1987)

Event Date 11/28/2023

Event Type  Injury  

Manufacturer Narrative

The device was returned to olympus for evaluation.The esg 400 unit was inspected & tested.The technician was unable to confirm the reported complaint.It was noted that the emc seal came off from position, but no other functional problem found.All functions and outputs were in standard specifications.The emc seal needs to be re-installed ( it was not damaged).The unit passed functional test, output test, leakage test, power on/off the unit for twenty times and no error popped up.The device was then checked with the test metron electrosurgery analyzer for power outputs using 2 different test monopolar handswitches (wb979013 and wb979014), test cables, and the test double footswitch.Verified all the cut and coag output power, high frequency leakage current, contact quality monitor function, current/power consumption, and electrical safety test measured values were within standard requirement (see attached inspection results).No abnormal error occurred during activation.The generator passed the inspection.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.This report has been submitted by the importer under this mdr report number 2429304-2023-00406.

Event Description

A company representative, on behalf of the customer, reported a loud ding from the hf unit "esg-400" during a therapeutic transurethral resection of a bladder tumor.The doctor was using a bipolar loop and the esg-400.When the doctor heard the loud noise from hf unit "esg-400" there was a glitch and the doctor perforated the bladder.The patient was transferred to another room for a cystogram.The initial case was aborted and the equipment was quarantined.This medwatch requires two reports.The related patient identifiers are as follows: (b)(6) : hf unit "esg-400".(b)(6) : hf-resection electrode "plasmaloop", loop, large, 24 fr., 12°-30°, esg turis.This medwatch represents (b)(6).

• Brand Name: HF UNIT "ESG-400"
• Type of Device: ELECTROSURGICAL GENERATOR ESG-400
• 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 14513 ; GM 14513
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18389730
• MDR Text Key: 331298769
• Report Number: 3003724334-2023-00068
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2023
• 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: 12/05/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2019
• 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: HF-RESECTION ELECTRODE "PLASMALOOP"
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White