MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR., 12°-30°, ESG TURIS; WA22706S

Model Number	WA22706S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2024
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 loop was already broken upon opening the packaging of the hf-resection electrode.Here were no reports of patient harm.
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.Based on the results of the investigation, a definitive root cause could not be determined as the device was not returned for evaluation.However, based on available information, the damage pattern reported is implausible for a device just removed from it's original sterile packaging.The damage would have to be caused during use.Therefore, it is likely that the cause of the reported issue is user mishandling, there was multiple use of a single use product, and wear/tear.The instructions for use (ifu) provides the following cautions: "caution risk of injury to the patient contact between the hf-resection electrode and metal parts, such as other endoscopic equipment, implants or stents can result in sparkover between the hf-resection electrode and the metal part.Always keep a distance of at least 10 mm between the hf-resection electrode and metal parts." "caution risk of injury to the patient use extreme caution when using electrosurgery in close proximity to or in direct contact with any metal objects.Do not activate the hf-resection electrode while any portion of the hf-resection electrode tip is in contact with another metal object.This can cause uncontrolled heating of the hf-resection electrode and may result in damage and breakage to the hf-resection electrode tip.If excessive heating or physical forces cause damage to the hf-resection electrode tip, broken device fragments may remain in the body, possibly requiring additional surgery for removal." olympus will continue to monitor field performance for this device.

• Brand Name: HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR., 12°-30°, ESG TURIS
• Common Device Name: WA22706S
• 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: 20191556
• Report Number: 9610773-2024-02165
• Device Sequence Number: 7058372
• Product Code: FAS
• UDI-Device Identifier: 14042761085356
• UDI-Public: 14042761085356
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2024

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: WA22706S
• Device Lot Number: 1000143060
• Was Device Available for Evaluation?: No
• 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: 08/12/2024
• Supplement Date Received by Manufacturer: 11/22/2024
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2024
• 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