MAUDE Adverse Event Report: TECHNOMED EUROPE DISPOSABLE MONOPOLAR PROBE; ELECTRODE, NEEDLE

Model Number	MP214-3.0/1
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
When removing probe from metal sheath, dr noticed the probe sheath was missing.All pieces retrieved.Fda safety report id # (b)(4).

• Brand Name: DISPOSABLE MONOPOLAR PROBE
• Common Device Name: ELECTRODE, NEEDLE
• Manufacturer (Section D): TECHNOMED EUROPE
• MDR Report Key: 15527699
• Report Number: MW5112363
• Device Sequence Number: 12227762
• Product Code: GXZ
• UDI-Device Identifier: 08718375866313
• UDI-Public: (01)08718375866313
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MP214-3.0/1
• Device Lot Number: 053433
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/30/2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Unknown
• Patient Weight: 94 KG