MAUDE Adverse Event Report: WICKIMED (HUIZHOU) MEDICAL EQUIPMENT MANUFACTURING TTUNGSTEN MICRO NEEDLE 3CM, STRAIGHT, 10 PK; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESS

Model Number 138505-10

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2022

Event Type  malfunction  

Event Description

Voluntary distributor report the distributor reported on behalf of the customer that the device, 138505-10, tungsten micro needle 3cm, straight, was being used during a spine surgery procedure on (b)(6) 2022 when it was reported during use of this product, a medical accident occurred in which an insulated tube fell off and entered the body.Fortunately, the insulating tube was sucked out and remained inside the body.Further assessment questioning found that the tube was sucked out by suction and was retrieved from the patient.The procedure was completed with another tungsten micro needle and the surgery was extended for an unknown amount of surgery time.The current status of the patient was reported as recovering.There was no report of medical intervention or extended hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Capa: (b)(4);] dhr of p2139004; picture; video; test plan and test report; dhr list_2017~2022; training record.

• Brand Name: TTUNGSTEN MICRO NEEDLE 3CM, STRAIGHT, 10 PK
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESS
• Manufacturer (Section D): WICKIMED (HUIZHOU) MEDICAL EQUIPMENT MANUFACTURING; tang jiao xing wang street,; zhongkai hi-tech zone,; huizhou, guangdong 51603 5; CH 516035
• Manufacturer (Section G): WICKIMED (HUIZHOU) MEDICAL EQUIPMENT MANUFACTURING; tang jiao xing wang street,; lilin town, zhongkai hi-tech; huizhou, guangdong 51603 5; CH 516035
• Manufacturer Contact: mac lai ; tang jiao xing wang street,; zhongkai hi-tech zone; huizhou, guangdong 51603-5 ; CH 516035
• MDR Report Key: 16158920
• MDR Text Key: 308860768
• Report Number: 3010601992-2022-00002
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 06970739450046
• UDI-Public: (01)06970739450046(17)251022(10)P2139004
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K100258
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 11/07/2022

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
• Device Operator: Health Professional
• Device Model Number: 138505-10
• Device Catalogue Number: 138505-10
• Device Lot Number: P2139004
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/19/2022
• Initial Date FDA Received: 01/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention