MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. E-Z CLEAN L-WIRE LAP 33CM; E-Z CLEAN WIRE L-WIRE LAP 33 CM

Catalog Number	0100
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 12/3/2018.Batch # unk.The lot/batch was not provided; therefore, the manufacturing records could not be reviewed.
Event or Problem Description
It was reported that during a lap cholecystectomy, they were using a 0100 l wire and the insulation is detached from the wire portion.They are getting melting on them.The insulation is melting off.The black insulation is melting at the distal tip during the activation of energy to remove the gallbladder from the liver bed.Case completed with the same device, the issue was noticed near the end of the case.There were no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 12/20/2018.Additional information received: did the detached insulation fall into the patient?not that was noticed or documented from the complaint was the detached insulation removed from the patient?none was seen falling into patient was there any burn to the patient or user? as stated previous no patient burns.

• Brand Name: E-Z CLEAN L-WIRE LAP 33CM
• Common Device Name: E-Z CLEAN WIRE L-WIRE LAP 33 CM
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 8125594
• Report Number: 1721194-2018-00057
• Device Sequence Number: 1913698
• Product Code: GEI
• UDI-Device Identifier: 10614559100660
• UDI-Public: 10614559100660
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K913281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2018

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: 0100
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/19/2018
• Supplement Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 12/03/2018
• Supplement Report FDA Received Date: 12/20/2018
• Patient Sequence Number: 1