MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH RESECTION ELECTRODE LOOP; ENDOSCOPE, AC-POWERED AND ACCESSORIES

Model Number A22201C HF - RESECTION ELECTRODE

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/15/2022

Event Type  malfunction  

Event Description

Ref# (b)(4) resection electrode loop 24f, lot: 100033994, exp: 2023-09-27 loop broke inside the patient.Fda safety report id #(b)(4).

• Brand Name: RESECTION ELECTRODE LOOP
• Type of Device: ENDOSCOPE, AC-POWERED AND ACCESSORIES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH
• MDR Report Key: 15456051
• MDR Text Key: 300341838
• Report Number: MW5112145
• Device Sequence Number: 1
• Product Code: GCP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2023
• Device Model Number: A22201C HF - RESECTION ELECTRODE
• Device Lot Number: 100033994
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other