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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LINA MEDICAL POLSKA SP. Z.O.O ENDOSCOPIC BIPOLAR LOOP FOR LSH, 200X100MM
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LINA MEDICAL POLSKA SP. Z.O.O ENDOSCOPIC BIPOLAR LOOP FOR LSH, 200X100MM Back to Search Results
Model Number BL-200
Device Problem Torn Material (3024)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/26/2015
Event Type  malfunction  
Event Description
"allegedly, after looping the bipolar loop around the uterus, the doctor went to pull back on the handle to get the loop snug around the uterus.However, the entire handle came apart and began to spark.".
 
Manufacturer Narrative
Lina medical polska sp z o.O.- the manufacturer is currently waiting for the product to be returned and investigated, shipment is arranged by the logistics department.
 
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Brand Name
ENDOSCOPIC BIPOLAR LOOP FOR LSH, 200X100MM
Type of Device
ENDOSCOPIC BIPOLAR LOOP
Manufacturer (Section D)
LINA MEDICAL POLSKA SP. Z.O.O
rolna 8a
sady
tarnowo podgorne 62-08 0
PL  62-080
Manufacturer Contact
joanna madajska
formervangen 5
glostrup DK-26-00
DA   DK-2600
12225009
MDR Report Key4908362
MDR Text Key6832514
Report Number3007699067-2015-00004
Device Sequence Number1
Product Code HIN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130305
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/07/2015
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 Operator Health Professional
Device Expiration Date05/31/2017
Device Model NumberBL-200
Device Catalogue NumberBL-200
Device Lot Number14201
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/12/2015
Initial Date FDA Received07/09/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2014
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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