MAUDE Adverse Event Report: MEDLINE RENEWAL; LIGASURE SMALL JAW FT10 COMPATIBLE

Catalog Number LF1212ACRH

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/01/2022

Event Type  Injury  

Event Description

According to the facility during a tubal ligation the tissue was sticking to the teflon coated jaws of the device causing the tissue to be ripped and bleeding to occur.

Manufacturer Narrative

According to the facility during a tubal ligation the tissue was sticking to the teflon coated jaws of the device causing the tissue to be ripped and bleeding to occur.Per the facility the patient required sutures to stop the bleed.The sample was returned for evaluation and a definitive root cause could not be determined.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: LIGASURE SMALL JAW FT10 COMPATIBLE
• 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: 15716815
• MDR Text Key: 302876718
• Report Number: 3032391-2022-00013
• 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: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: LF1212ACRH
• Device Lot Number: 479863
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2022
• Date Manufacturer Received: 10/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other