MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. MEGA POWER MONOPOLAR FOOT PEDAL, FOOT SWITCH, 12FT; MEGA POWER MONOPOLAR FOOT SWITCH

Catalog Number 1400

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.The lot/batch was not provided; therefore, the manufacturing records could not be reviewed.

Event Description

It was reported that while using a monopolar foot pedal, activation will continue after the surgeon steps off of the foot pedal until the electrode is removed from tissue.The sales rep confirmed that the foot pedal is not sticking and that activation works properly with hand activation.Procedure was completed with the same equipment.There were no patient consequences reported.

• Brand Name: MEGA POWER MONOPOLAR FOOT PEDAL, FOOT SWITCH, 12FT
• Type of Device: MEGA POWER MONOPOLAR FOOT SWITCH
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• Manufacturer (Section G): LINEMASTER SWITCH CORP.
• Manufacturer Contact: milt garrett ; 11506 south state street; draper, UT 84020
• MDR Report Key: 7518874
• MDR Text Key: 108866219
• Report Number: 1721194-2018-00011
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10614559101933
• UDI-Public: 10614559101933
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/18/2018

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 Catalogue Number: 1400
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/18/2018
• Initial Date FDA Received: 05/16/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1