MAUDE Adverse Event Report: COVIDIEN US APPOSE; STAPLE, REMOVABLE

Catalog Number 8886803712

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2016

Event Type  malfunction  

Event Description

While a procedure was being set up in the or, a surgerical technician took the covering off of a covidien skin stapler.A piece of the stapler fell off.The entire device was removed from the field before the start of the procedure.There was no harm to the patient.

• Brand Name: APPOSE
• Type of Device: STAPLE, REMOVABLE
• Manufacturer (Section D): COVIDIEN US; 60 middletown ave.; north haven CT 06473
• MDR Report Key: 6192644
• MDR Text Key: 62923420
• Report Number: 6192644
• Device Sequence Number: 1
• Product Code: GDT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 8886803712
• Device Lot Number: J5L1010LX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/05/2016
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1