MAUDE Adverse Event Report: MEDLINE RENEWAL; LF1212AC @LIGASURE SM JAW INSTRUMENT

Catalog Number LF1212ACR

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 01/04/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported that during a bilateral salpingectomy, the ligasure jaw was identified to be difficult to release.Reportedly, during release the ligasure jaw stuck to the left fallopian tube and the patient experienced bleeding to the site.The bleeding was able to be controlled, however, an additional thirty (30) minutes were added to the procedure and the patient received additional anesthesia.The method utilized to control the reported bleeding was not identified by the reporting facility.No serious injury, additional medical intervention, or follow-up care was reported.No sample was returned for evaluation.A root cause for the reported incident was unable to be determined.Due to the reported need for medical intervention, this medwatch is being filed.If additional relevant information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that the ligasure jaw was identify to be difficult to release.

• Type of Device: LF1212AC @LIGASURE SM JAW INSTRUMENT
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock avenue; redmond OR 97756 1876
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753 ; 2249311458
• MDR Report Key: 9672404
• MDR Text Key: 190748572
• Report Number: 3032391-2020-00001
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LF1212ACR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/16/2020
• Initial Date FDA Received: 02/05/2020
• 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): Required Intervention