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

Model Number BL-200

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 11/03/2021

Event Type  malfunction  

Event Description

Tip of lina endoscopic bipolar loop broke off inside of the patient.Tip was retrieved without incident.

• Brand Name: LINA BIPOLAR LOOP¿
• Type of Device: COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR (AND ACCESSORIES)
• Manufacturer (Section D): LINA MEDICAL APS; 2500 bee cave road; bldg 1, suite 300; austin TX 78746
• MDR Report Key: 12933050
• MDR Text Key: 281748947
• Report Number: 12933050
• Device Sequence Number: 1
• Product Code: HIN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/19/2021

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
• Device Model Number: BL-200
• Device Catalogue Number: BL-200
• Device Lot Number: 200804
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/19/2021
• Device Age: 1 YR
• Date Report to Manufacturer: 12/06/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female