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

Catalog Number ER420

Device Problem Device Difficult to Setup or Prepare (1487)

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

Event Date 05/02/2013

Event Type  malfunction  

• Brand Name: LIGACLIP
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC.; 4545 creek road,; cincinnati, OH 45242
• MDR Report Key: 3888149
• Report Number: 3888149
• Device Sequence Number: 1
• Product Code: FZP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: ER420
• Device Lot Number: J4AP2T
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/02/2014
• Event Location: Hospital
• Date Report to Manufacturer: 06/23/2014
• Patient Sequence Number: 1