MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. E-Z CLEAN BLADE MOD 4.0IN BNS; E-Z CLEAN BLADE MOD 4.0 INCH BNS

Catalog Number	0014AMBN
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.
Event or Problem Description
It was reported that during an unknown procedure, an insulation fell off from the tip during use.It is unknown how the procedure was completed.There were no adverse consequences for the patient reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 9/12/2018.Investigation summary: customer reported that the insulation fell off from the tip during use.Photo review and physical product inspection found the modified insulation was pulled off and detached from the electrode.Damage was observed on detached modified insulation and also electrode insulation.The cause of the report is most likely the result of the blade being exposed to heavy pressure, possibility during the cleaning of the blade.A review of the of the possible dhr's shows this product was originally manufactured to specifications and there is no evidence of device defect or malfunction.

• Brand Name: E-Z CLEAN BLADE MOD 4.0IN BNS
• Common Device Name: E-Z CLEAN BLADE MOD 4.0 INCH BNS
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 7765168
• Report Number: 1721194-2018-00027
• Device Sequence Number: 11077486
• Product Code: GEI
• UDI-Device Identifier: 10614559103210
• UDI-Public: 10614559103210
• Combination Product (Y/N): N
• PMA/510(K) Number: K862221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2018

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 Catalogue Number: 0014AMBN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Initial Date Received by Manufacturer: 07/12/2018
• Supplement Date Received by Manufacturer: 07/12/2018
• Initial Report FDA Received Date: 08/08/2018
• Supplement Report FDA Received Date: 09/12/2018
• Patient Sequence Number: 1