MAUDE Adverse Event Report: LINA MEDICAL APS LINA GOLD LOOP, REF. EL-240-8

Model Number EL-240-8

Device Problem Break (1069)

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

Event Date 09/12/2017

Event Type  malfunction  

Manufacturer Narrative

Manufacturer is waiting for the device to be returned in order to perform examination.

Event Description

During use lina gold loop broke and heated wire came in contact with the patient bowel.(unintended tissue effect).

• Brand Name: LINA GOLD LOOP, REF. EL-240-8
• Type of Device: LINA GOLD LOOP, REF. EL-240-8
• Manufacturer (Section D): LINA MEDICAL APS; formervangen 5; glostrup, DK-26 00; DA DK-2600
• Manufacturer (Section G): LINA MEDICAL POLSKA SP. Z O.O.; 8a rolna, sady; tarnowo podg[?]rne, 62-08 0; PL 62-080
• Manufacturer Contact: joanna mazur ; formervangen 5; glostrup, DK-26-00 ; DA DK-2600
• MDR Report Key: 7032628
• MDR Text Key: 219162638
• Report Number: 3007699067-2017-00004
• Device Sequence Number: 1
• Product Code: HIN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070315
• 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: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2019
• Device Model Number: EL-240-8
• Device Catalogue Number: EL-240-8
• Device Lot Number: 1607037
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention