MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE; ELECTRODE, ELECTROSURGICAL

Model Number	WA47506S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted upon receiving additional information.
Event or Problem Description
Olympus was informed of the following event from (b)(6) health services ((b)(6) mdip#(b)(4)): during a therapeutic fibroid resection, the tip of the olympus electrode loop broke inside the patient.The tip of the device was retrieved from the patient with an unspecified surgical instrument.The intended surgery was completed with a similar device.There was an unspecified surgical delay to remove the fragment and get a new device.There was no patient harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer¿s investigation and the results of the device history records (dhr) review.The dhr for this device were reviewed and all records indicated the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.A definitive root cause was not identified.Based on the available information, the legal manufacturer determined the probable cause of the failure is likely due to wear and tear; he loop at the distal end of the electrode wears out during use and may break, burn or melt.

• Brand Name: HF-RESECTION ELECTRODE
• Common Device Name: ELECTRODE, ELECTROSURGICAL
• 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: 13596314
• Report Number: 9610773-2022-00080
• Device Sequence Number: 12220939
• Product Code: JOS
• UDI-Device Identifier: 14042761085042
• UDI-Public: 14042761085042
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K161600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/14/2025
• Device Model Number: WA47506S
• Device Catalogue Number: WA47506S
• Device Lot Number: 1000067135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2022
• 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: 01/25/2022
• Supplement Date Received by Manufacturer: 03/14/2022
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 04/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/09/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED SURGICAL INSTRUMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown