MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE "PLASMALOOP ¿ SMALL, 30°"; RESECTION ELECTRODES

Model Number	WA47505S
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D1 full device name: hf-resection electrode "plasmaloop ¿ small, 30°", small loop, 24 fr., 12°-30°, for tcris the device referenced in this report was not returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The olympus employee reported on behalf of the customer that the electrode fell into the patient's body during a gynecological transcervical resectoscope (tcr) procedure.No health hazard reported.Additional information for patient's current condition, procedural details and outcome of the procedure were requested but not available at the time of the report.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, it is likely the reported event occurred due to usage-related wear and tear which has contributed to a breakage.The loop wire at the distal end of the high frequency -resection electrode wears out during use and could break, burn or melt.However, the subject device was not returned and the root cause could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-RESECTION ELECTRODE "PLASMALOOP ¿ SMALL, 30°"
• Common Device Name: RESECTION ELECTRODES
• 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: 18320675
• Report Number: 9610773-2023-03614
• Device Sequence Number: 20645621
• Product Code: JOS
• UDI-Device Identifier: 14042761085035
• UDI-Public: 14042761085035
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2024

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 Model Number: WA47505S
• 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: 11/17/2023
• Supplement Date Received by Manufacturer: 03/15/2024
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 03/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female