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

Model Number	E2350H
Medical Device Problem Codes	Failure to Cut (2587); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	09/21/2020
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, intra-operatively, the pencil was not cutting as it typically did and was slow and inadequate.Cords were checked, and it was observed that the tones did not sound like the usual pencil during activation.The surgeon tried to continue with procedure, but was not getting tissue effect and asked to have cut/coag turned up from 25/25 (typical setting) to 40/40.The issue persisted and the other tip was opened and inserted in original pencil with same results.The surgeon finished the procedure with the 2nd tip not functioning/cutting well, at a setting of 40/40.The patient developed a hematoma post operatively which was observed at check up.The patient had a bleeding less than 250cc and developed a hematoma post op which was observed at first post op check up.

• 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: 10731714
• Report Number: 1717344-2020-01267
• Device Sequence Number: 3180121
• Product Code: GEI
• UDI-Device Identifier: 10884524000626
• UDI-Public: 10884524000626
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K955836
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/24/2020

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 Model Number: E2350H
• Device Catalogue Number: E2350H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2020
• Initial Report FDA Received Date: 10/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1