MAUDE Adverse Event Report: ETHICON ENDO SURGERY, LLC LIGACLIP; LIGACLIP, 10-M/L

Model Number LIGACLIP 10-M/L

Device Problem Difficult to Insert (1316)

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

Event Date 03/13/2015

Event Type  Injury  

Event Description

Clip was malfunctioning.Stapler would not completely grab tissue when engaged.Staples were not being completely discharged from the stapler.Reason for use: laparoscopic converted to open cholecystectomy.

• Brand Name: LIGACLIP
• Type of Device: LIGACLIP, 10-M/L
• Manufacturer (Section D): ETHICON ENDO SURGERY, LLC; guaynabo PR 00969
• MDR Report Key: 4745496
• MDR Text Key: 5768456
• Report Number: MW5042441
• Device Sequence Number: 1
• Product Code: FZP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: LIGACLIP 10-M/L
• Device Catalogue Number: ER320
• Device Lot Number: L4FG9M
• 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: 76 YR