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

Device Problem Material Twisted/Bent (2981)

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 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 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-RESECTION ELECTRODE "PLASMALOOP", LOOP, LARGE, 24 FR., 12°-30°, ESG TURIS
• Type of Device: 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 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18389723
• MDR Text Key: 331296298
• Report Number: 9610773-2023-03751
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171965
• 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: 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
• Date Manufacturer Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: HF UNIT "ESG-400"
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White