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

Model Number	180-1022
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Title: prospective evaluation of the hemorrhoid energy treatment for the management of bleeding internal hemorrhoids source: https://www.F6publishing.Com world j gastrointest endosc 2021 august 16; 13(8): 329-335 doi: 10.4253/wjge.V13.I8.329 issn 1948-5190 (online).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to a literature, a prospective study evaluated the outcomes of patients with grade i or ii internal hemorrhoids who underwent hemorrhoid energy treatment from (b)(6) 2016 to (b)(6) 2019.The het bipolar system was used in all patients.There were 73 patients in the study and postoperative complications included persistent rectal bleeding.Six patients required a second procedure due to bleeding.Three patients had persistent bleeding after repeat procedure.

• Brand Name: HET
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 12735899
• Report Number: 1717344-2021-01491
• Device Sequence Number: 16507600
• Product Code: GEI
• UDI-Device Identifier: 10884521511132
• UDI-Public: 10884521511132
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,literatur
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/02/2021

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 11/02/2021
• 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: 50 YR