MAUDE Adverse Event Report: COVIDIEN LP MULTIFIRE PREMIUM; STAPLE, REMOVABLE (SKIN)

Model Number 059037

Device Problems Failure to Fire (2610); Device Dislodged or Dislocated (2923)

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

Event Date 03/25/2019

Event Type  malfunction  

Event Description

During surgical procedure, skin staplers x 2 did not fire when triggered, then the magazine fell out and became detached from the staple gun.It was ruled out that education on the use of the device was not the issue in this case.The staplers were given to the company representative to inspect and report back to us on their findings.

• Brand Name: MULTIFIRE PREMIUM
• Type of Device: STAPLE, REMOVABLE (SKIN)
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 8530953
• MDR Text Key: 142469077
• Report Number: 8530953
• Device Sequence Number: 1
• Product Code: GDT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 059037
• Device Catalogue Number: 059037
• Device Lot Number: J9A0478Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/18/2019
• Event Location: Hospital
• Date Report to Manufacturer: 04/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25185 DA