MAUDE Adverse Event Report: COVIDIEN APPOSE* ULC 35 WIDE SKIN STAPLER; STAPLE, REMOVABLE (SKIN)

Model Number 8886803712

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).Post market vigilance (pmv) led an evaluation of six skin staplers opened by the account.The visual inspection of the devices noted the instruments were partially applied.The tab at the proximal end of one instrument was broken.The observed condition was confirmed to be caused by the incorrect removal of a piece of the paper wrap that covers the stapler handle prior to use.However, it is noted that the instructions for use do not establish guidelines to remove the unit from the package.If the device handle is actuated with the packaging still attached to the device, the tab will break causing the device to malfunction.This can cause staple jamming, unsuccessful firing, staple malformation and other similar outcomes.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.

Event Description

According to the reporter, while using a skin stapler, the staples became stuck inside the stapler therefore the users were forced to open another stapler but the problem was repeated again and again.

• Type of Device: STAPLE, REMOVABLE (SKIN)
• Manufacturer (Section D): COVIDIEN; zona franca de san isidro; carretara san isidro km17; santo domingo ; DR
• Manufacturer (Section G): COVIDIEN; zona franca de san isidro; carretara san isidro km17; santo domingo ; DR
• Manufacturer Contact: matthew amaral ; 60 middletown ave; north haven
• MDR Report Key: 5844341
• MDR Text Key: 51124987
• Report Number: 9612501-2016-00414
• Device Sequence Number: 1
• Product Code: GDT
• Combination Product (y/n): N
• Reporter Country Code: LE
• PMA/PMN Number: K900486
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2016
• 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 Model Number: 8886803712
• Device Catalogue Number: 8886803712
• Device Lot Number: J4F0704LX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1