MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. E-Z CLEAN BALL 5IN; E-Z CLEAN BALL 5 INCH

Catalog Number	0009
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during an unknown procedure, the part of the blue coating (near to the ball electrode) was broken in the case of colposcopy.X-ray was to be performed for finding out the broken part.Patient impact unknown.
Additional Manufacturer Narrative
(b)(4).Date sent: 9/7/2018.Investigation summary: received one each used sample.Lot number reported to be 173902.No packaging was received with the product.Product is the 5 inch ball electrode.Confirm a 4-5mm split in the insulation.Immediately adjacent is a secondary split of 2mm.The device was possibly sliced but unable to determine for certain.There are no impression marks or signature marks noted.The insulation is split from distal to proximal which is highly uncommon (to split in this direction) especially close to a larger ball.Insulation may have been "nicked" by something at some point, unable to determine where, when or how this may have occurred.There is heavy eschar on the ball portion.No visible initiation marking seen under magnification.Exact cause undetermined.A review of the dhr shows this product was originally manufactured to specifications and there is no evidence of device defect or malfunction.

• Brand Name: E-Z CLEAN BALL 5IN
• Common Device Name: E-Z CLEAN BALL 5 INCH
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 7770148
• Report Number: 1721194-2018-00029
• Device Sequence Number: 13767840
• Product Code: GEI
• UDI-Device Identifier: 10614559100042
• UDI-Public: 10614559100042
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2018

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 Expiration Date: 08/31/2022
• Device Catalogue Number: 0009
• Device Lot Number: 173902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• Initial Date Received by Manufacturer: 07/25/2018
• Supplement Date Received by Manufacturer: 07/25/2018
• Initial Report FDA Received Date: 08/09/2018
• Supplement Report FDA Received Date: 09/07/2018
• Patient Sequence Number: 1