MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE** LINEAR STAPLER; STAPLE, IMPLANTABLE

Catalog Number TX30B

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2014

Event Type  malfunction  

Event Description

It was reported that during an unknown procedure, the packaging was torn (tyvek).There were no patient consequences.Unknown how case was completed.

Manufacturer Narrative

(b)(4).Information anticipated, but unavailable at this time.Additional information: was the packaging torn when opening? yes it was.

Manufacturer Narrative

(b)(4).Additional information: the tx60b package was visually inspected and tyvek delamination was confirmed.Tyvek tore and stuck to the blister when package was opened due to tyvek delamination (separation of tyvek layers).Tyvek delamination makes it difficult to remove the device from the package using sterile technique.The package blister was acceptable without any defects and there was evidence of seal transfer from the tyvek to the blister flange on the entire circumference of the blister.The only damage found on the package was the delamination of the tyvek which occurred during the opening of the package.Package sterile integrity was not affected.Possible causes of tyvek delamination are tyvek quality, seal strength, or opening technique.Lot history records for l4ey8x, product code tx30b, were reviewed.No protocols, defects, non-conformances or quarantine noted.The product met all in-process and finished goods specifications upon release of the product.

• Type of Device: STAPLE, 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: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4236930
• MDR Text Key: 5067552
• Report Number: 3005075853-2014-07724
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/22/2014

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: TX30B
• Device Lot Number: L4EY8X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/15/2014
• Initial Date FDA Received: 11/07/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2014
• 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