MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, LARGE, 24 FR., 12°-30°, PK TURIS; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICA

Model Number	WA22607S
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was evaluated by olympus.The evaluation found that the reported complaint of "red light kept blinking, check the fluids" was not duplicated during activation.Olympus received only one plasma loop electrode component number w7109994, physical lot number 1100403970, which belonged to the correct model wa22607s as printed on the returned paperwork.It was noted that the hf cable was not returned with the electrode.A visual inspection of the received condition found the loop wire was broken, melted, and balled up on both sides.There is also a charred stain on the loop due to thermal damage.The fork tubes appeared to be bent inward.However, the white insulation shaft was straight, and its proximal end had no physical damage.The electrode was then checked with test equipment such as a generator (pk superpulse), a working element (wa22367a), and a test hf cable.The generator recognized the electrode and prompted a default setting of pk/turis, tp2/180, and des/100.It was observed that the broken loop would generate heat and was able to coagulate a piece of saline-soaked tissue when the coagulation mode or cutting mode was activated.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported to olympus that during a procedure, the hf-resection electrode plasma loop was not working properly.The loop failed; the large red loop light kept blinking to check the fluids.This was one piece from the lot.The customer switched out the loop and finished the procedure.There were no reports of patient harm associated with this event.During the evaluation of the device, it was noted that the wire at the distal end of the device was melted.This report is to capture the reportable malfunction of the melted distal end wire noted at estimation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Correction to g2, adding health professional.Information was inadvertently not included on the initial medwatch.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely the report issue occurred due to improper handling on the part of the user.However, a definitive root cause could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, LARGE, 24 FR., 12°-30°, PK TURIS
• Common Device Name: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICA
• 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: 16718374
• Report Number: 9610773-2023-01016
• Device Sequence Number: 1791858
• Product Code: FAS
• UDI-Device Identifier: 14042761085165
• UDI-Public: 14042761085165
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2023

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: WA22607S
• Device Catalogue Number: WA22607S
• Device Lot Number: 1100403970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2023
• 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: 03/17/2023
• Supplement Date Received by Manufacturer: 06/27/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown