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

Catalog Number TX30V

Device Problems Defective Component (2292); Device Packaging Compromised (2916); Packaging Problem (3007); Torn Material (3024)

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

Event Date 03/15/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Information was not provided by the initial contact.Information anticipated, but unavailable at this time.At the time of this submission, the device has not been returned for analysis.If the device is received at a later date a supplemental medwatch will be sent.

Event Description

It was reported that during an unknown procedure, there was defective packaging.The outer packaging was ripped and torn.The device wasn't used.Another like device was used to complete the procedure.There were no adverse consequences for the patient.It is unknown if device will be returned.

Manufacturer Narrative

(b)(4).The tx30v package was visually inspected and it was found that the ripped and torn tyvek occurred while opening the product and that the sterile barrier was fully in place before the package was opened.Tyvek delamination was confirmed.Tyvek ripped and stuck to the blister flange when package was opened due to tyvek delamination (separation of tyvek layers.) tyvek delamination causes the package to be difficult to open and difficult to remove the device from the package using sterile technique.The package blister was fine with no defects and there was evidence of seal transfer from the tyvek to the blister flange on the entire circumference of the blister.Possible causes of tyvek delamination are tyvek quality, seal strength, or opening technique.Lot history records for m4h02u, product code tx30v, 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.Lot history records for m4h02u, product code tx30v, 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 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• Manufacturer Contact: milton garrett ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133378865
• MDR Report Key: 5007492
• MDR Text Key: 23217752
• Report Number: 3005075853-2015-05126
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 07/24/2015

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: 12/31/2019
• Device Catalogue Number: TX30V
• Device Lot Number: M4H02U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/02/2015
• 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