MAUDE Adverse Event Report: MEDLINE RENEWAL; LF1212ACRH

Catalog Number LF1212ACRH

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/07/2022

Event Type  Injury  

Event Description

According to the facility on (b)(6) 2022, 'when the ligasure was being used, it smoked, and a piece of melted plastic was noted in the jaws'.

Manufacturer Narrative

According to the facility on (b)(6) 2022, 'when the ligasure was being used, it smoked, and a piece of melted plastic was noted in the jaws'.Per the facility they were able to use another device to complete the procedure without patient injury or medical intervention.The sample is available but has not been returned for evaluation.No additional information is available at this time.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Type of Device: LF1212ACRH
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock ave; redmond OR 97756
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 15635973
• MDR Text Key: 302051848
• Report Number: 3032391-2022-00012
• Device Sequence Number: 1
• Product Code: NUJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: LF1212ACRH
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other