MAUDE Adverse Event Report: BLACK & BLACK SURGICAL, INC. B&B E-P ELECTROSURGICAL DISSECTOR; 14.5''(36.5CM), CURVED ON STRAIGHT, STRAIGHT

Model Number	B65227
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	01/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report was received from a distributor on 01/25/2018 that a spot of the insulation layer "melt" and burnt the patient.A photo of the instrument was attached.From initial evaluation of the picture, it is apparent that the dissector was damaged due to misuse by the customer.The dissector insulation was somehow scored during use or during reprocessing and when it was used again after the damage occurred, the exposed metal on the dissector caused the device to arc.There is no other explanation as to why the dissector would arc.After the initial report, additional information was not able to be obtained.If further information is obtained, a follow up report will be filed.
Event or Problem Description
Event as described by customer: "a spot of the insulation layer melt and burnt the patient.".

• Brand Name: B&B E-P ELECTROSURGICAL DISSECTOR; 14.5''(36.5CM), CURVED ON STRAIGHT, STRAIGHT
• Common Device Name: DISSECTOR
• Manufacturer (Section D): BLACK & BLACK SURGICAL, INC.; 5238 royal woods parkway; suite 170; tucker GA 30084
• MDR Report Key: 7293583
• Report Number: 3006142527-2018-00001
• Device Sequence Number: 1249958
• Product Code: GEI
• UDI-Device Identifier: B089B652270
• UDI-Public: B089B652270
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K072124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Health Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: B65227
• Device Catalogue Number: B65227
• Device Lot Number: F17
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2018
• Initial Report FDA Received Date: 02/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other