MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. ULTRAVAC; APPARATUS, EXHAUST, SURGICAL

Model Number 2110-10EC

Device Problems Failure to Read Input Signal (1581); Failure to Shut Off (2939)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/06/2019

Event Type  malfunction  

Event Description

Esu pencil activated by attending surgeon.Device did not turn off when device-on button no longer pushed.No apparent harm to patient.

• Brand Name: ULTRAVAC
• Type of Device: APPARATUS, EXHAUST, SURGICAL
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 s state st; draper UT 84020
• MDR Report Key: 8703773
• MDR Text Key: 148199693
• Report Number: 8703773
• Device Sequence Number: 1
• Product Code: FYD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/21/2019

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: 2110-10EC
• Device Lot Number: 7270
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/21/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/17/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 9855 DA