MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, LARGE, 24 FR., 12°/16°, PK TURIS; ELECTRODES, ELECTROSURGICAL

Model Number	WA22603S
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported, the electrode had a burnt tip.Caused by a working element.The issue, occurred 30 minutes into resecting, during a resection procedure.There were no reports of patient harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Additional information added to field d8, h3, h4 and h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device was not returned to olympus for evaluation of the reported issue.In speaking with olympus technical assistance center (tac), the customer reported that the model name electrode had a burnt tip caused by a working element.Troubleshooting efforts were made and the customer was instructed to immediately cease use of the 744000 | serial (b)(6) unit.It was planned to do some troubleshooting through methodical process of elimination using known reliable generator unit, handpiece and wa22603s sp plasmaloop - large 12 to see whether phenomena can be isolated to a single component.It is believed that they will recommend the 744000 | serial (b)(6) be sent to olympus for evaluation based on the results of the investigation, it is likely the following led to the malfunction: the damage to the distal end of the electrode is that ignition of the electrode in non-conductive liquid, in this case sterile water.Usually, only saline solution is used from the beginning to fill cavities, e.G.The bladder, and to rinse during a bipolar application.The complained occurrence of the error "check detergent / electrode" (e006 for e.G.Esg-400 using the bipolar cable wa00014a) can be attributed to various causes.A growing tissue deposit on the electrodes.Increased contact resistances due to poorly or insufficiently mated contacts on the conveyor or the connection cable.Increased contact resistances due to defective contacts on the conveyor or the connection cable.All possible causes have in common is that the electrical resistance between the bipolar electrode and the generator increases, and then the error message is triggered.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, LARGE, 24 FR., 12°/16°, PK TURIS
• Common Device Name: ELECTRODES, ELECTROSURGICAL
• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19747435
• Report Number: 9610773-2024-01714
• Device Sequence Number: 6532686
• Product Code: FAS
• UDI-Device Identifier: 14042761085134
• UDI-Public: 14042761085134
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: WA22603S
• Device Lot Number: 1000128510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2024
• Supplement Date Received by Manufacturer: 08/23/2024
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2023
• 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
• Patient Sex: Unknown