MAUDE Adverse Event Report: COVIDIEN COVIDIEN-HET BIPOLAR ELECTROCAUTERY SYSTEM FORCEPS; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number 180-1022

Device Problem Arcing (2583)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 03/09/2023

Event Type  Injury  

Event Description

During a routine hemorrhoidectomy, the patient sustained a 1-2 mm linear superficial rectal burn with no tissue necrosis when the het bipolar forceps reportedly "sparked" when not in contact with the selected tissue area.The het bipolar forceps device was used with its designated components: het monitor and the valley lab ft10 power generator.Patient was discharged home after the normal post procedure recovery period for a hemorrhoidectomy, with no unexpected pain or bleeding.Clinic follow-up found the patient to be without complaints or any side effects.

• Brand Name: COVIDIEN-HET BIPOLAR ELECTROCAUTERY SYSTEM FORCEPS
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 16683583
• MDR Text Key: 312813430
• Report Number: MW5116323
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/30/2023

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/19/2023
• Device Model Number: 180-1022
• Device Lot Number: FPCANL0396
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/04/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White