MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, LARGE, 24 FR., 12°-30°, ESG TURIS; RESECTION ELECTRODES WITH HF CABLE

Model Number	WA22707S
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Internal Organ Perforation (1987)
Date of Event	11/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned to olympus for evaluation.The electrode distal end was received in damaged condition.Its fork tubes were bent outwards and widened about 8mm.The cutting loop was severely bent, but no charred marks observed on the distal insulation tubes.After assembling the electrode into a test working element wa22367a, and checked that the distance between our test telescope wa2t430a and the noninsulated distal tip of the hf-resection electrode is approximately 3mm which is within specifications (per ifu: at least 2mm).The hf cable was then checked with customer generator esg-400 (b)(4) and recognized displaying saline mode with default settings cut 200w/effect2 and oag 120/effect2.During activation on either saline cut or coagulation mode with the cutting loop submerged in normal saline (0.9% nacl) as irrigation fluid, the cutting loop was heated up generating energy, but no loud ding/noise or glitch was observed.Therefore, the reported complaint was not confirmed.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 2429304-2023-00407.
Event or Problem 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).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information, based on the legal manufacturer's final investigation.A review of the device history record found no deviations, that could have caused or contributed to the reported issue.It has been over 1 year, since the subject device was manufactured.Based on the results of the investigation, it has been determined, that there is no relationship between the reported adverse event and the subject device.The event can be detected/prevented, by following the instructions for use (ifu), which state: ¿a suitable replacement device must be provided, during an application¿.This supplemental report includes a correction to d9, from the initial medwatch.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, LARGE, 24 FR., 12°-30°, ESG TURIS
• Common Device Name: RESECTION ELECTRODES WITH HF CABLE
• 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: 18389723
• Report Number: 9610773-2023-03751
• Device Sequence Number: 19838679
• Product Code: FAS
• UDI-Device Identifier: 14042761085363
• UDI-Public: 14042761085363
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K171965
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: WA22707S
• Device Lot Number: 1000123554
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2023
• Supplement Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 12/23/2023
• Supplement Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HF UNIT "ESG-400"
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White