LIGASURE COVLF1737

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-16 for LIGASURE COVLF1737 manufactured by Sterilmed, Inc..

Event Text Entries

[127352583] A sterilmed reprocessed ligasure is defective. It could be activated and the generator unit made the appropriate noise, but the hand piece did not cauterize.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 8077238
• MDR Report Key: 8077238
• Date Received: 2018-11-16
• Date of Report: 2018-11-14
• Date of Event: 2018-11-12
• Report Date: 2018-11-14
• Date Reported to FDA: 2018-11-14
• Date Reported to Mfgr: 2018-11-16
• Date Added to Maude: 2018-11-16
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 0

• Brand Name: LIGASURE
• Generic Name: ELECTROSURGICAL, CUTTING, COAGULATION, REPROCESSED
• Product Code: NUJ
• Date Received: 2018-11-16
• Model Number: COVLF1737
• Catalog Number: COVLF1737
• Lot Number: 2046858 OR 2045462
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 0
• Device Event Key: 0
• Manufacturer: STERILMED, INC.
• Manufacturer Address: 5010 CHESHIRE PARKWAY N. SUITE 2 PLYMOUTH MN 55446 US 55446

Device Sequence Number: 1

• Brand Name: LIGASURE
• Generic Name: ELECTROSURGICAL, CUTTING, COAGULATION, REPROCESSED
• Product Code: GEI
• Date Received: 2018-11-16
• Model Number: COVLF1737
• Catalog Number: COVLF1737
• Lot Number: 2046858 OR 2045462
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: STERILMED, INC.
• Manufacturer Address: 5010 CHESHIRE PARKWAY N. SUITE 2 PLYMOUTH MN 55446 US 55446

Patients

Patient Number	Treatment	Outcome	Date
1	0		2018-11-16