MAUDE Adverse Event Report: LINA MEDICAL, INC. LINA BIPOLAR LOOP; COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR (AND ACCESSORIES)

Model Number BL-200

Device Problems Break (1069); Detachment Of Device Component (1104); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/30/2014

Event Type  malfunction  

Event Description

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.

• Brand Name: LINA BIPOLAR LOOP
• Type of Device: COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR (AND ACCESSORIES)
• Manufacturer (Section D): LINA MEDICAL, INC.; 1856 corporate drive, suite 13; norcross GA 30093
• MDR Report Key: 3842815
• MDR Text Key: 19762919
• Report Number: 3842815
• Device Sequence Number: 1
• Product Code: HIN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 05/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: BL-200
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/07/2014
• Event Location: Hospital
• Date Report to Manufacturer: 06/02/2014
• Patient Sequence Number: 1
• Patient Age: 41 YR