MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH*BIPOLAR FORCEPS MACRO; HAND CONTROLLED ELECTROSURGICAL DIATHERMY SYSTEM CONDUCTING UNIT

Catalog Number	EBF01
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The lot history records were reviewed and the manufacturing criteria were met prior to the release of this lot.
Event or Problem Description
It was reported that it was found at an agency that the article number on the package was different from that of the label.When the product was checked, it was found that the device was packed in a box of ebf02.The article number on the label, the product itself, tyvek and the barcode was ebf01.There were no adverse consequences to the patient.

• Common Device Name: HAND CONTROLLED ELECTROSURGICAL DIATHERMY SYSTEM CONDUCTING UNIT
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8171812
• Report Number: 3005075853-2018-15185
• Device Sequence Number: 11298272
• Product Code: GEX
• UDI-Device Identifier: 10705036011880
• UDI-Public: 10705036011880
• Combination Product (Y/N): N
• PMA/510(K) Number: K904993
• 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
• Report Date (Section B): 12/06/2018

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: 06/30/2023
• Device Catalogue Number: EBF01
• Device Lot Number: R93W2M
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 12/17/2018
• Patient Sequence Number: 1