MAUDE Adverse Event Report: LINA MEDICAL U.S. LINA GOLD LOOP (FOR LAPAROSCOPIC); NONE

Model Number EL-200-8

Device Problem Break (1069)

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

Event Date 02/02/2014

Event Type  Injury  

Event Description

Lina gold loop for laparoscopic use, broke as the surgeon was beginning to use it.Replacement given to surgeon which worked appropriately.Mfr; please note that we do not send products to the mfr, but you may arrange for pick-up by calling my number.

• Brand Name: LINA GOLD LOOP (FOR LAPAROSCOPIC)
• Type of Device: NONE
• Manufacturer (Section D): LINA MEDICAL U.S.; 1856 corporate drive; ste 135; norcross GA 30093
• MDR Report Key: 3642725
• MDR Text Key: 22265695
• Report Number: MW5034639
• Device Sequence Number: 1
• Product Code: HIN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Model Number: EL-200-8
• Device Lot Number: 13161
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR