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

Model Number	WA22707S
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Olympus received a medwatch# mw5107612 report with a malfunction event of " product was found to be broken while using during procedure.Product was being used during case and dr.Said it was "burnt"/ broken while using in patient.Case continued with new product".There was no patient harm or injury reported due to the event.No user injury reported.
Additional Manufacturer Narrative
The subject device was not returned for evaluation.The cause of the reported issue is unknown at this time.Supplemental report(s) will be submitted should any relevant new information is available.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Investigation results: since the product for this complaint was not returned , the investigation is based solely on the information provided by the customer and the sbc ( service business center).The product was sold on 17 december 2021.A typical wire breakage with signs of heat (burnt) at the distal end of the electrode is described.Please note that it was not stated in the event description if a wire fragment was missing.The defective electrode was replaced and the procedure was completed without further interruption.Additionally, neither an error message from the generator nor injuries to the patient were reported.Cause according to our investigators, the cause of the reported issue is most likely due to wear and tear.In general, the customer is required to check the function of all devices used prior to a procedure.Additionally, according to the ifu, a suitable replacement device must be provided during an application.Dhr (device history record ) review: a manufacturing and quality control review was performed for device wa22707s with lot number 1000084431.There is no non-conformity associated with this device with respect to the described issue.Olympus will continue to monitor complaints for this device.

• Brand Name: HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, LARGE, 24 FR., 12°-30°, ESG TURIS
• Common Device Name: HF-RESECTION ELECTRODE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662955
• MDR Report Key: 14172068
• Report Number: 9610773-2022-00148
• Device Sequence Number: 5742246
• Product Code: FAS
• UDI-Device Identifier: 14042761085363
• UDI-Public: 14042761085363
• Combination Product (Y/N): N
• 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: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2022

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 Catalogue Number: WA22707S
• Device Lot Number: 1000084431
• 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: 03/25/2022
• Supplement Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 04/21/2022
• Supplement Report FDA Received Date: 05/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2021
• 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