MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP*MCA; CLIP, IMPLANTABLE

Catalog Number MCM20

Device Problems Product Quality Problem (1506); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 01/09/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint indicated broken package.One individual sealed package was returned without sales unit carton.The package was visually inspected and it was confirmed that cuts in the tyvek lid were present.There was adhesive tape stuck on the top surface of the tyvek lid and cuts in the tyvek appeared to have occurred when something that had been taped onto the package was cut off.There were three pieces of tape and four cuts were made with a sharp bladed object from the outside in making roughly-parallel cuts through the tyvek.The adhesive tape was cut through with the tyvek.The cuts may have been caused when someone was cutting an object that was lying atop the package or cutting into sales unit carton.Blades are not used in the packaging process and adhesive tape is not used in the packaging process.All product is placed into cartons immediately after sealing and 100% visual inspection.Batch history review indicates no nonconformances or defects occurred during packaging process and there was no rework or unusual handling.Cuts and damage on the package lid most likely caused external to packaging process.The product met all in-process and finished goods specifications upon release of the product.

Manufacturer Narrative

(b)(4).Information anticipated, but unavailable at this time.

Event Description

It was reported by the affiliate that during an unknown procedure, the sterile package was broken before using.Another like device was used to complete the procedure.There were no adverse consequences for the patient reported.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 0096 9
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 0096 9
• Manufacturer Contact: janice hinsey ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133373009
• MDR Report Key: 3585439
• MDR Text Key: 11706994
• Report Number: 3005075853-2014-00563
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K820837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: MCM20
• Device Lot Number: K4CT01
• Other Device ID Number: BATCH # NI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1