MAUDE Adverse Event Report: CONMED CORPORATION MEDCON CORP HYFRECATOR 2000; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number HYFRECATOR 2000 #7900115

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Pain (1994); Electric Shock (2554)

Event Date 04/23/2021

Event Type  malfunction  

Event Description

A (b)(6) male patient in clinic for bilateral vasectomy.Grounding pad placed on thigh, patient felt shock from pad, hyfrecator turned down and again patient felt shock from pad.Immediately discontinued use, per provider.Patient returned to clinic after discharge c/o shooting pain in his back.Evaluated by provider and discharged to home.Fda safety report id# (b)(4).

• Brand Name: MEDCON CORP HYFRECATOR 2000
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED CORPORATION ; largo FL 33773
• MDR Report Key: 11789851
• MDR Text Key: 249684435
• Report Number: MW5101216
• Device Sequence Number: 1
• Product Code: GEI
• 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: 05/04/2021

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
• Device Operator: Health Professional
• Device Model Number: HYFRECATOR 2000 #7900115
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/06/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 36 YR
• Patient Weight: 64