MAUDE Adverse Event Report: LINA MEDICAL POLSKA SP. Z.O.O ENDOSCOPIC BIPOLAR LOOP

Model Number BL-200

Device Problem Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

According to (b)(6) the loop split at the loop tip while in use.Allegedly, pieces of the hand pieces also fell off when this happened.

Manufacturer Narrative

(b)(4) - the mfr is currently waiting for the product to be returned and investigated, shipment is arranged by the (b)(4).

• Brand Name: ENDOSCOPIC BIPOLAR LOOP
• 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 (Section G): LINA MEDICAL APS; formervangen 5; glostrup DK-2 600; DA DK-2600
• Manufacturer Contact: joanna madajska ; 12225009
• MDR Report Key: 4491415
• MDR Text Key: 5568168
• Report Number: 3007699067-2015-00002
• Device Sequence Number: 1
• Product Code: HIN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130305
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/03/2015

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 Date: 03/01/2017
• Device Model Number: BL-200
• Device Catalogue Number: BL-200
• Device Lot Number: 14123
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/15/2015
• Initial Date FDA Received: 02/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1