MAUDE Adverse Event Report: MODERN MEDICAL EQUIMENT MANFUCTURING LTD GOLDVAC SLIM; PUSH BUTTON SMOKE EVACUATION PENCIL

Model Number	GOLDVAC SLIM
Medical Device Problem Codes	Fracture (1260); Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/02/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer facility reported that the air channel on the smoke evacuation electrosurgical pencil broke apart, and a piece of plastic fell into the patient's abdomen.No injury reported.Device not yet returned for evaluation.
Event or Problem Description
This report is being raised on the basis of device failure.The smoke evacuation air channel broke off of the electrosurgical pencil and a fragment fell into the patient's abdomen.

• Brand Name: GOLDVAC SLIM
• Common Device Name: PUSH BUTTON SMOKE EVACUATION PENCIL
• Manufacturer (Section D): MODERN MEDICAL EQUIMENT MANFUCTURING LTD; dong xing industrial area; kang le lu, shan xia district; dongguan, ; CH
• MDR Report Key: 8750524
• Report Number: 1319774-2019-00001
• Device Sequence Number: 19230299
• Product Code: GEI
• UDI-Device Identifier: 00815198012380
• UDI-Public: 00815198012380
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K103375
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/06/2019
• Report Date (Section F): 06/06/2019

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: GOLDVAC SLIM
• Device Catalogue Number: 60-7610-001
• Device Lot Number: 160606
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/06/2019
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/06/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2019
• Initial Report FDA Received Date: 07/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1