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

Model Number ER3200

Device Problems Device Difficult to Setup or Prepare (1487); Failure to Form Staple (2579)

Patient Problem No Information (3190)

Event Date 03/29/2014

Event Type  Injury  

Event Description

During a laparoscopic cholestectomy while applying the final clip on a artery the ligaclip did not clip after 2-3 attempts.Previously, it had clipped successfully x3 but on the last clip they had to try multiple times before it finally clipped.The final clip was thought to be successful so another lipaclip was not opened; however, the ligaclip failed to reload.

• Brand Name: LIGACLIP 10-M/L
• Type of Device: LIGACLIP 10-M/L
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC
• MDR Report Key: 3788318
• MDR Text Key: 4442130
• Report Number: MW5035864
• 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: 04/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ER3200
• Device Lot Number: L4E39W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2014
• 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: 50 YR
• Patient Weight: 92