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

Catalog Number TLC75

Device Problems Device Packaging Compromised (2916); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/17/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during an unknown procedure, the nurse open product for a case and the packaging was compromised and the paper was partially torn.The nurse was concerned that it was not sterile.Another like device was used to complete the procedure.There were no adverse consequences for the patient.

• Brand Name: PROXIMATE RELOADABLE LINEAR CUTTER
• 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: 5071150
• MDR Text Key: 26028262
• Report Number: 3005075853-2015-05692
• 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
• Report Date: 08/22/2015

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: 06/14/2020
• Device Catalogue Number: TLC75
• Device Lot Number: M4HU0J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2015
• 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