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

Model Number WA22507D

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/10/2023

Event Type  Injury  

Event Description

The customer reported to olympus the high frequency resection electrode broke at the end of a therapeutic hysteroscopy.The procedure was completed using the same device, but the broken piece of the device was not retrieved and remained within the patient.No additional medical intervention was taken, and there is no plan to retrieve the fragment as the location was undetermined and the device ends seemed to be burned.The hospital stay of the patient was not extended due to the device malfunction, and there were no additional reports of patient harm or impact.

Manufacturer Narrative

The device was not returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

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 and to provide a correction to (d9 and h3).The device was returned to olympus for inspection, and the customer's complaint/reportable malfunction was confirmed.The complete evaluation results are as followed: the loop is broken and the wire ends are melted.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 the suggested event occurred due to wear and tear.The loop at the distal end of the electrode might break, burn, or melt during use.However, the root cause of the suggested event could not be identified.Olympus will continue to monitor field performance for this device.

Event Description

The patient was under general anesthesia and the state of health of the patient was good.Unknown if the patient had pre-existing conditions associated with the patient at the time of the event.The device was inspected prior to use.The reported problem did not affect the procedure as it occurred at the end of the procedure.No imaging completed to confirm the presence of the broken device and the device was not retrieved due to impossible to find it inside the patient.

• Brand Name: HF-RESECTION ELECTRODE, LOOP
• Type of Device: ELECTROSURGICAL CUTTING & COAGULATION DEVICE
• 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: 17484623
• MDR Text Key: 320665988
• Report Number: 9610773-2023-02165
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761068236
• UDI-Public: 14042761068236
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K100275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA22507D
• Device Lot Number: 1000101534
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ESG-400 WITH S/N: (B)(6).
• Patient Outcome(s): Other