MAUDE Adverse Event Report: ETHICON LEGACLIP; CLIP, IMPLANTABLE

Model Number UNKNOWN LIGACLIP

Device Problem Mechanical Jam (2983)

Patient Problem Insufficient Information (4580)

Event Date 04/12/2022

Event Type  malfunction  

Event Description

According to the reporter, during gastrectomy procedure, the device's ligaclip jammed.Replaced by a non-medtronic device.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: LEGACLIP
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON
• MDR Report Key: 17531833
• MDR Text Key: 321403207
• Report Number: MW5138744
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: UNKNOWN LIGACLIP
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1