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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LINA MEDICAL APS LINA BIPOLAR LOOP; COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR (AND ACCESSORIES)
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LINA MEDICAL APS LINA BIPOLAR LOOP; COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR (AND ACCESSORIES) Back to Search Results
Model Number BL-160
Device Problem Material Protrusion/Extrusion (2979)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/20/2017
Event Type  malfunction  
Event Description
During first case the lina loop was used after severing the cervix and the loop was removed.Doctor noticed that wire was exposed.Rep was present.During last case the same thing happened.Doctor told rep he did not want to use the lina loop until they fixed this issue.No patient complication; able to complete both cases without issue.Called into company.Sent back for evaluation.
 
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Brand Name
LINA BIPOLAR LOOP
Type of Device
COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR (AND ACCESSORIES)
Manufacturer (Section D)
LINA MEDICAL APS
816 congress avenue
suite 1400
austin TX 78701
MDR Report Key6479669
MDR Text Key72345863
Report Number6479669
Device Sequence Number1
Product Code HIN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 04/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date08/01/2017
Device Model NumberBL-160
Device Catalogue NumberBL-160
Device Lot Number14351
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/20/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/04/2017
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer04/04/2017
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age43 YR
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