MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE** RELOADABLE LINEAR STAPLER - 60 MM; STAPLE, IMPLANTABLE

Catalog Number TX60B

Device Problems Crack (1135); Noise, Audible (3273)

Patient Problems Other (for use when an appropriate patient code cannot be identified) (2200); Unknown (for use when the patient's condition is not known) (2202)

Event Date 11/27/2014

Event Type  malfunction  

Event Description

It was reported that during an open pneumonectomy procedure, the stapler was fired and it cracked and made a "cracking sound" on stump of bronchus.No visible staples after they cut the airway with knife with the device still on segmental bronchus.Open bronchus with no staplers deployed.There may be patient complications but we haven't heard back from the surgeon yet.The patient had bronchoscopically after procedure.Case completed by suturing closed the bronchus.

Manufacturer Narrative

(b)(4).Information asked for but unknown or not provided during initial contact.Information anticipated, but unavailable at this time.No device received for analysis at time of submission of 3500a device evaluation: no device received for analysis at time of submission of 3500a.When additional information is received and/or the device analysis has been completed, a supplemental medwatch will be sent.

• 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: 4418001
• MDR Text Key: 5372749
• Report Number: 3005075853-2015-00364
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/01/2014

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 Catalogue Number: TX60B
• Device Lot Number: L4F30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/30/2014
• Initial Date FDA Received: 01/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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