MAUDE Adverse Event Report: STERILMED, INC.; ELECTROSURGICAL, CUTTING, COAGULATION, REPROCESSED

Model Number	COVLF1737
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/03/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The ligasure hand piece did not work.We tried two different machines.When that did not correct the problem, we switched hand pieces and that corrected the problem.

• Brand Name: NA
• Common Device Name: ELECTROSURGICAL, CUTTING, COAGULATION, REPROCESSED
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire pkwy n. ste 2; plymouth MN 55446
• MDR Report Key: 8288777
• Report Number: 8288777
• Device Sequence Number: 2463276
• Product Code: GEI
• UDI-Device Identifier: 10888551044462
• UDI-Public: (01)10888551044462(17)20190515(10)2055013
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 01/04/2019
• Report Date (Section F): 01/04/2019

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: Health Professional
• Device Model Number: COVLF1737
• Device Catalogue Number: COVLF1737
• Device Lot Number: 2055013
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/30/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Weight: 55
• Date Report Sent to FDA: 01/04/2019