LINA BIPOLAR LOOP BL-200 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-05-07 for LINA BIPOLAR LOOP BL-200 * manufactured by Lina Medical, Inc..

Event Text Entries

[19762919] Ceramic insulated tip of lina bipolar loop device broke during the procedure. It was imbedded in the specimen, removed from the patient, and handed off the field.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3842815
• MDR Report Key: 3842815
• Date Received: 2014-05-07
• Date of Report: 2014-05-07
• Date of Event: 2014-04-30
• Report Date: 2014-05-07
• Date Reported to FDA: 2014-05-07
• Date Reported to Mfgr: 2014-06-02
• Date Added to Maude: 2014-06-02
• 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: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: LINA BIPOLAR LOOP
• Generic Name: COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR (AND ACCESSORIES)
• Product Code: HIN
• Date Received: 2014-05-07
• Model Number: BL-200
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: LINA MEDICAL, INC.
• Manufacturer Address: 1856 CORPORATE DRIVE, SUITE 13 NORCROSS GA 30093 US 30093

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-05-07