MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. E-Z CLEAN MEGAFINE NEEDLE 2IN; E-Z CLEAN MEGAFINE NEEDLE 2 INCH

Model Number	0118
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 7/23/2019.Batch # unk.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.
Event or Problem Description
It was reported that during a spinal cord tumour a piece of diathermy needle point insulation became detached during surgical procedure.It was noted by the surgeon when a piece fell off into the sterile field during the procedure.Device had been in use for approximately 30min.Diathermy scabbard was in use.There were no knocks or other trauma of the product noted prior to the issue.No scratch pad was in use.Reusable monopolar diathermy pencil was in use at the time.Items was retrieved, checked for completeness.No known harm occurred to the patient.
Additional Manufacturer Narrative
(b)(4).Date sent: 5/13/2020.Additional information: the customer reported insulation detached.A photo was provided and reviewed.In the photo the modified insulation was detached from the electrode.This insulation has a cut that runs the length of the detached insulation.Also seen abrasion and cuts/nicks in this damaged area.Charring was observed under where the detached insulation was located.Indicating the electrode was used after the damage to the insulation.The most likely cause of the damage is consistent with the electrode being exposed to excessive mechanical forces such as contact with other sharp instrument or object that damaged the insulation and resulted in the piece of insulation becoming detached.The complaint is confirmed as user damage.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.

• Brand Name: E-Z CLEAN MEGAFINE NEEDLE 2IN
• Common Device Name: E-Z CLEAN MEGAFINE NEEDLE 2 INCH
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 8819724
• Report Number: 1721194-2019-00105
• Device Sequence Number: 2839225
• Product Code: GEI
• UDI-Device Identifier: 10614559101278
• UDI-Public: 10614559101278
• Combination Product (Y/N): N
• PMA/510(K) Number: K081791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2019

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: 06/30/2023
• Device Model Number: 0118
• Device Catalogue Number: 0118
• Device Lot Number: 184009
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/27/2019
• Supplement Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 05/13/2020
• Patient Sequence Number: 1