MAUDE Adverse Event Report: ETHICON ENDO-SURGERY LIGACLIP 12L; LIGACLIP CLIP APPLIER

Model Number LIGACLIP 12 L

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  malfunction  

Event Description

Clips fell off caused bleeding, had to use hemostatic agent to decrease bleeding.

• Brand Name: LIGACLIP 12L
• Type of Device: LIGACLIP CLIP APPLIER
• Manufacturer (Section D): ETHICON ENDO-SURGERY
• MDR Report Key: 7544293
• MDR Text Key: 109425367
• Report Number: MW5077453
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LIGACLIP 12 L
• Device Catalogue Number: ER240
• Device Lot Number: R92D9R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 25 YR