MAUDE Adverse Event Report: STERILMED, INC.; SCALPEL, ULTRASONIC, REPROCESSED

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/31/2020

Event Type  malfunction  

Event Description

The surgical team noticed white pad on the jaw of harmonic scalpel becoming dislodged on the video monitor.Instrument was taken out of the patient's abdomen and the white pad, then the white pad came off the device at that time outside the patient.A new device was opened, case resumed and finished.

• Type of Device: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire pkwy n ste 2; plymouth MN 55446
• MDR Report Key: 9719888
• MDR Text Key: 179743842
• Report Number: 9719888
• Device Sequence Number: 1
• Product Code: NLQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/04/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/18/2020
• Type of Device Usage: N
• Patient Sequence Number: 1