MAUDE Adverse Event Report: LINA MEDICAL POLSKA SP. Z O. O. LINA GOLD LOOP; COAGULATOR-CUTTER, ENDOSCOPIC

Model Number EL-240-8

Device Problem Torn Material (3024)

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

Event Date 10/30/2015

Event Type  malfunction  

Manufacturer Narrative

Manufacturer - lina medical (b)(4) is correctly waiting for the product to be evaluated.Lot number of the defective device was not provided in the complaint report hence no data regarding the manufacturing date and expiration date is available.Device not returned to manufacturer yet.

Event Description

The wire on the gold loop broke preventing amputation of the uterus from the cervix.A second loop was opened to complete the amputation.The manufacturer opened a complaint file and asked follow-up questions.Manufacturer intends to send a shipping label for the device to be returned for a full investigation.What was the original intended procedure? laparoscopic supracervical hysterectomy.Device usage problem: device failed (e.G.Broke, couldn't get it to work or stopped working).

Event Description

The wire on the gold loop broke preventing amputation of the uterus from the cervix.A second loop was opened to complete the amputation.The manufacturer opened a complaint file and asked follow-up questions.Manufacturer intends to send a shipping label for the device to be returned for a full investigation.What was the original intended procedure? laparoscopic supracervical hysterectomy device usage problem: device failed (e.G.Broke, couldn't get it to work or stopped working).

• Brand Name: LINA GOLD LOOP
• Type of Device: COAGULATOR-CUTTER, ENDOSCOPIC
• Manufacturer (Section D): LINA MEDICAL POLSKA SP. Z O. O.; rolna 8a, sady; tarnowo podgórne; sady, 62-08 0; PL 62-080
• Manufacturer (Section G): LINA MEDICAL APS; formervangen 5; glostrup, DK260 0; DA DK2600
• Manufacturer Contact: joanna madajska ; rolna 8a, sady; tranowo podgórne; PL 62-080 ; 12225009
• MDR Report Key: 5317646
• MDR Text Key: 34803442
• Report Number: 3007699067-2015-00008
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/07/2015,01/25/2016

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 Model Number: EL-240-8
• Device Catalogue Number: EL-240-8
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/07/2015
• Initial Date Manufacturer Received: 12/07/2015
• Initial Date FDA Received: 12/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 44 YR