MAUDE Adverse Event Report: TECHNOMED EUROPE TECHNOMED EUROPE; DISPOSABLE SUBDERMAL NEEDLE ELECTRODE, CORKSCREW

Model Number	TE/S50715-001
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The corkscrew electrode was inserted into a patient's scalp, was removed, and subsequently repositioned in another position in the patient's scalp.Upon screwing the electrode back in, the health professional noticed that it was screwing but not stopping (indicates it is in), took her hand away to check if it was in, and the plastic cap and cord came away with no needle inside.The health professional observed that the needle electrode was still lodged in the patient's scalp.Thereafter, attempts were made to remove the needle electrode with forceps, but eventually a small incision had to be made in order to be able to remove the needle electrode from the scalp.
Event or Problem Description
The corkscrew electrode was inserted into a patient's scalp, was removed, and subsequently repositioned in another position in the patient's scalp.Upon screwing the electrode back in, the health professional noticed that it was screwing but not stopping (indicates it is in), took her hand away to check if it was in, and the plastic cap and cord came away with no needle inside.The health professional observed that the needle electrode was still lodged in the patient's scalp.Thereafter, attempts were made to remove the needle electrode with forceps, but eventually a small incision had to be made in order to be able to remove the needle electrode from the scalp.
Event or Problem Description
The corkscrew electrode was inserted into a patient's scalp, was removed, and subsequently repositioned in another position in the patient's scalp.Upon screwing the electrode back in, the health professional noticed that it was screwing but not stopping (indicates it is in), took her hand away to check if it was in, and the plastic cap and cord came away with no needle inside.The health professional observed that the needle electrode was still lodged in the patient's scalp.Thereafter, attempts were made to remove the needle electrode with forceps, but eventually a small incision had to be made in order to be able to remove the needle electrode from the scalp.
Additional Manufacturer Narrative
The corkscrew electrode was inserted into a patient's scalp, was removed, and subsequently repositioned in another position in the patient's scalp.Upon screwing the electrode back in, the health professional noticed that it was screwing but not stopping (indicates it is in), took her hand away to check if it was in, and the plastic cap and cord came away with no needle inside.The health professional observed that the needle electrode was still lodged in the patient's scalp.Thereafter, attempts were made to remove the needle electrode with forceps, but eventually a small incision had to be made in order to be able to remove the needle electrode from the scalp.This is a final report (follow-up number 1), initial report number: 9710376-2021-00002.

• Brand Name: TECHNOMED EUROPE
• Common Device Name: DISPOSABLE SUBDERMAL NEEDLE ELECTRODE, CORKSCREW
• Manufacturer (Section D): TECHNOMED EUROPE; amerikalaan 71; maastricht-airport, limburg 6199 AE; NL 6199 AE
• Manufacturer (Section G): TECHNOMED ASIA; k.i. trikencana kav. 4-5, jl.; kopo katapang km 11; bandung, jawa barat 40921 ; ID 40921
• Manufacturer Contact: sanne habets ; amerikalaan 71; maastricht-airport, limburg 6199 -AE ; NL 6199 AE
• MDR Report Key: 12811651
• Report Number: 9710376-2021-00002
• Device Sequence Number: 4906107
• Product Code: GXZ
• UDI-Device Identifier: 08718375861547
• UDI-Public: 08718375861547
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K130136
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2021

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 Expiration Date: 07/01/2024
• Device Model Number: TE/S50715-001
• Device Catalogue Number: TE/S50715-001
• Device Lot Number: 049662
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2021
• Supplement Date Received by Manufacturer: 11/10/2021
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2021
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown