MAUDE Adverse Event Report: NEW DEANTRONICS LTD CLEANCOAT; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	E3773-36C
Medical Device Problem Codes	Arcing (2583); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during laparoscopic surgery, the device sparked and caused a small burn under the trocar.

• Brand Name: CLEANCOAT
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): NEW DEANTRONICS LTD; 12f no 51 sec 4 chong yang roa; taipei 23675 ; TW 23675
• MDR Report Key: 10246842
• Report Number: 1717344-2020-00708
• Device Sequence Number: 572834
• Product Code: GEI
• UDI-Device Identifier: 10884521550803
• UDI-Public: 10884521550803
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K153265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/08/2020

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: 06/30/2024
• Device Model Number: E3773-36C
• Device Catalogue Number: E3773-36C
• Device Lot Number: 1904170X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2020
• Initial Report FDA Received Date: 07/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR