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

Model Number	A22201C
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report has been submitted by the importer under this mdr report number 2429304-2023-00272 the investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported that during a therapeutic urology procedure using the hf resection electrode, the loop broke off and fell into the patient and was unable to be located.It remained in the patient.The procedure was prolonged "dramatically." it was reported that the condition of the patient and the diagnostic outcome was impacted by the failure, but it was not specified how.The procedure was completed with another device.Reportedly, a diagnostic intervention will be undertaken to locate the missing device piece left in the patient¿s body (mri/x-ray).Additional follow up has been conducted regarding the broken piece left in the patient and the patient outcome; however, the information was not available at the time of report.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information, based on the legal manufacturer's final investigation and device evaluation.Additionally, to provide correction to the initial with information inadvertently left out (a2, a3, e4 and g2) and to provide an update to field (h3).The device was evaluated by olympus.The electrode loop is broken on both sides and the electrode fork is deformed.A ceramic insulating tube is broken.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, it is likely, that the reported event occurred, due to the application of excessive force.As well as, improper handling.However, the root cause of the reported event could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-RESECTION ELECTRODE, LOOP
• Common Device Name: UNIT, ELECTROSURGICAL, ENDOSCOPIC
• 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: 17702520
• Report Number: 9610773-2023-02490
• Device Sequence Number: 17829035
• Product Code: GCP
• UDI-Device Identifier: 14042761036648
• UDI-Public: 14042761036648
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K790071
• 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,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2024

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: A22201C
• Device Lot Number: 1000112793
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2023
• Supplement Date Received by Manufacturer: 07/12/2024
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2023
• 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: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: FY24-EMEA-01
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Sex: Male