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	11/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The problem occurred with the second corkscrew they used during the procedure, the first one went fine.The user inserted it a half turn, but it could not be inserted completely into the skin as the hub started turning.She had no grip on the needle anymore.Then, she tried to pull it out, but the needle did not come out due to lack of grip because of the loose hub.The surgeon was in a hurry, which is why they placed a new corkscrew and left the defective one as is.After the surgery, the surgeon used a little surgical instrument (forceps) to remove the needle.1mm at a time, he pulled it out.The patient bled quite a lot after the needle came out.The needle was still attached to the lead wire.Due to using pressure, the needle was deformed.The wound was staunched and bleeding stopped after a while.No stitching was necessary.

• 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: 12974279
• Report Number: 9710376-2021-00003
• Device Sequence Number: 4647177
• 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: Other Health Care Professional
• Remedial Action: Replace,Recall
• Type of Report: Initial
• Report Date (Section B): 12/08/2021

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 Expiration Date: 07/01/2024
• Device Model Number: TE/S50715-001
• Device Catalogue Number: TE/S50715-001
• Device Lot Number: 049989 OR 049528
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 12/10/2021
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES# 89126
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 56 YR
• Patient Sex: Male