MAUDE Adverse Event Report: ETHICON ENDO SURGERY INC. LIGACLIP MEDIUM; CLIP, IMPLANTABLE

Device Problems Migration or Expulsion of Device (1395); Failure to Form Staple (2579)

Patient Problems Inflammation (1932); Pain (1994); Scar Tissue (2060)

Event Date 10/05/2016

Event Type  Injury  

Event Description

Surgeon used ligaclip medium surgical clips (3) during a surgical procedure knowing patient had severe nickel allergy.Severe reaction of pain, scar tissues and inflammation occurred due to the clips.An additional surgery was performed (b)(6) 2018 to remove the surgical clips.At this time it was noted that one clip was not closed correctly and one clipped had migrated.All (3) surgical clips were removed.Patient is still recovering, but improving everyday.

• Brand Name: LIGACLIP MEDIUM
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO SURGERY INC.
• MDR Report Key: 8428448
• MDR Text Key: 139178741
• Report Number: MW5084972
• 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: Unknown
• Type of Report: Initial
• Report Date: 03/14/2019
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 47 YR
• Patient Weight: 95