MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. E-Z CLEAN NDLE BLUNT MOD 2.75IN; E-Z CLEAN NEEDLE BLUNT MOD 2.75 INCH

Model Number	0113M
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 9/29/2022.Investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the 0113m device was received with damage at the tip of the electrode as well as damage to black insulation.The electrode has excessive charred eschar and is melted on the distal tip of the device, and black insulation is slightly melted at the distal end.The likely cause of the damage to the 0113m electrode is contact with other instruments and likely was grasped with another instrument (i.E.Hemostats).The evidence suggests that the current strayed from the larger damaged area on the electrode, evident by the characteristics of being blackened and melted, which resulted in the reported flame.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.

• Brand Name: E-Z CLEAN NDLE BLUNT MOD 2.75IN
• Common Device Name: E-Z CLEAN NEEDLE BLUNT MOD 2.75 INCH
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 4545 creek road; cincinnati OH
• MDR Report Key: 15427657
• Report Number: 1721194-2022-00082
• Device Sequence Number: 7083678
• Product Code: GEI
• UDI-Device Identifier: 10614559101131
• UDI-Public: 10614559101131
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2022

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: 0113M
• Device Catalogue Number: 0113M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 09/15/2022
• Supplement Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown