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

Model Number	COVSCD396
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/09/2019
Type of Reportable Event	Malfunction
Event or Problem Description
During case, sterilmed sonicision cordless ultrasonic dissector began to smoke.The plastic piece that is on the tip of the dissector began to deteriorate.Item immediately taken out of use.No harm to patient.

• Brand Name: NA
• Common Device Name: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire pkwy n ste 2; plymouth MN 55446
• MDR Report Key: 8666420
• Report Number: 8666420
• Device Sequence Number: 16629556
• Product Code: NLQ
• UDI-Device Identifier: 10888551008020
• UDI-Public: (01)10888551008020
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/10/2019
• Report Date (Section F): 05/10/2019

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
• Operator of Device: Other
• Device Model Number: COVSCD396
• Device Catalogue Number: COVSCD396
• Device Lot Number: 2081413
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/04/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 115
• Date Report Sent to FDA: 05/10/2019