MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, LARGE, 24 FR., 12°-30°, ESG TURIS; WA22707S

Model Number	WA22707S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation of the event is still on-going.Should additional information be received, a supplemental report will be provided.
Event or Problem Description
The customer reported that an olympus hf resection electrode broke when used during a procedure.The customer confirmed that no further information was available concerning this event.However, there was no patient harm reported as a result of this event.
Event or Problem Description
Additional information was received from the initial reporter confirming an event date of (b)(6) 2024.The initial reporter went on to note that the procedure had not yet commenced as the loops broke during preparation.Reportedly, the intended procedure was confirmed completed without patient harm or delay.
Additional Manufacturer Narrative
This report is being submitted to capture additional event/patient information provided from the initial reporter.That information is documented in section b.Should additional information be received, another supplemental report will be provided.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.New information added to the following fields: d8, h3, h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over two (6) months since the subject device was manufactured.The device was not returned to olympus for inspection, and the customer's complaint/reportable malfunction was not confirmed.Based on the investigation results, electrode was broken, could not be identified.Injuries or damage to health are not reported.Complaint not confirmed, wrong handling by preparation on pre the procedure.The events can be detected and prevented in accordance with the following sections of the instructions for instructions for use: ¿not applicable¿ olympus will continue to monitor the field performance for this device.

• Brand Name: HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, LARGE, 24 FR., 12°-30°, ESG TURIS
• Common Device Name: WA22707S
• 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: 20522587
• Report Number: 9610773-2024-02572
• Device Sequence Number: 13037731
• Product Code: FAS
• UDI-Device Identifier: 14042761085363
• UDI-Public: 14042761085363
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/05/2024

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: WA22707S
• Device Lot Number: 1000148178
• 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: 10/13/2024
• Supplement Date Received by Manufacturer: 10/30/2024; 11/28/2024
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 10/30/2024; 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2024
• 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