MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER EDGE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	E2350H-GNSB
Medical Device Problem Codes	Fire (1245); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Full thickness (Third Degree) Burn (2696)
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, the pencil caught fire.There was no patient injury.
Additional Manufacturer Narrative
Additional information received.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a laparoscopic partial cecectomy, the raytec in the surgical field caught fire which resulted from prolonged use of the device at the trocar site to gain coagulation due to lack of effectiveness from the pencil with no change in settings.The pencil did not catch fire.The raytec fire was immediately extinguished.The patient sustained a burn from the heat accumulation at trocar site.The burn was full thickness skin necrosis, 0.5 cm of necrotic tissue.The injury care included sharp debridement and packing of the wound.Patient is currently still dressing the wound, but appears to be healing.The associated generator in use was a forcetriad generator.

• Brand Name: EDGE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 7978794
• Report Number: 1717344-2018-01362
• Device Sequence Number: 11157737
• Product Code: GEI
• UDI-Device Identifier: 20884524002214
• UDI-Public: 20884524002214
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K962044
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2019

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: E2350H-GNSB
• Device Catalogue Number: E2350H-GNSB
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/25/2018
• Supplement Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 10/18/2018
• Supplement Report FDA Received Date: 02/01/2019
• 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: Required Intervention
• Patient Age: 61 YR
• Patient Weight: 64