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

Model Number	180-1022
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ulcer (2274); No Code Available (3191)
Date of Event	11/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the patient came to the emergency room after how many the procedure was done, complaining of several rectal pain.Upon examination, it was discovered that the bipolar energy was applied below the dentate line and caused an ulcer which scabbed over.
Additional Manufacturer Narrative
Correction: if information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the procedure was done on (b)(6) 2018, and the patient came to the emergency room on friday (b)(6) 2108, complaining of several rectal pain.Upon examination, it was discovered that the bipolar energy was applied below the dentate line and caused an ulcer which scabbed over.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: HET
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder,co MA 80301 3299
• MDR Report Key: 8166793
• Report Number: 1717344-2018-01631
• Device Sequence Number: 16620168
• Product Code: GEI
• UDI-Device Identifier: 10884521511132
• UDI-Public: 10884521511132
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K140422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/17/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 180-1022
• Device Catalogue Number: 180-1022
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/20/2018
• Supplement Date Received by Manufacturer: 11/20/2018; 08/22/2019
• Initial Report FDA Received Date: 12/14/2018
• Supplement Report FDA Received Date: 01/04/2019; 09/17/2019
• 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: Other