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

Model Number A22201C

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/14/2023

Event Type  Injury  

Event Description

The customer reported to olympus that part of the hf-resection electrode broke off inside the patient and the doctor was unable to find it, but it showed up on the x-ray in the patient.Additional procedural details were requested but not provided.

• Brand Name: HF-RESECTION ELECTRODE
• Type of Device: ELECTRODE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 17737923
• MDR Text Key: 323300103
• Report Number: 2429304-2023-00293
• Device Sequence Number: 1
• Product Code: GCP
• UDI-Device Identifier: 14042761036648
• UDI-Public: 14042761036648
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/15/2023,09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A22201C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/15/2023
• Event Location: Hospital
• Date Report to Manufacturer: 08/15/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention