MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT GOLDLINE, HAND CONTROLLED WITH ULTRACLEAN BLADE ELECTRODE, ROCKER SWITCH; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	131319A
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation of the reported complaint is inconclusive.The device is not being returned and no photograph evidence was provided.Therefore, the reported failure could not be verified, root cause could not be identified.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution were found to have met all specifications prior to shipment and found no abnormalities that would contribute to this issue.(b)(4).The instructions for use (ifu) provides the user with information regarding proper care and use of this device.Per the ifu the user is also advised that these devices should be inspected before use.Visually examine the devices for obvious physical damage including: cracked, broken or otherwise distorted plastic parts; broken or significantly bent connector contacts; damage including cuts, punctures, nicks, abrasions, unusual lumps, significant discoloration and verify that the electrode is fully and securely seated in the handpiece before use.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
On behalf of their customer, the distributor reported issues involving item # 131319a , goldline, hand controlled with ultraclean blade electrode, rocker switch, lot # 201901244, that was experienced on (b)(6) 2020.It was reported only "hand control pencil sparks".It is noted that the issue occurred during surgery and there was no impact or injury to the patient.Additional information received indicated that the device was plugged into the cautery machine in the c-section room.Sparks came from the pencil tip upon immediate use, there were no flames.The device was used during a c-section and the issue occurred in a sterile field.The staff changed to a different disposable pencil tip and the procedure was completed.No other information was made available.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: GOLDLINE, HAND CONTROLLED WITH ULTRACLEAN BLADE ELECTRODE, ROCKER SWITCH
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua, mexico 31136 ; MX 31136
• MDR Report Key: 9831390
• Report Number: 3007305485-2020-00108
• Device Sequence Number: 16876133
• Product Code: GEI
• UDI-Device Identifier: 20653405056802
• UDI-Public: (01)20653405056802(11)190124(30)250(10)201901244
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K791137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 131319A
• Device Lot Number: 201901244
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2020
• Initial Report FDA Received Date: 03/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1