MAUDE Adverse Event Report: COVIDIEN LP APPOSE ULC; STAPLE, REMOVABLE (SKIN)

Model Number 8886803712

Device Problem Difficult to Open or Close (2921)

Patient Problem Insufficient Information (4580)

Event Date 09/16/2020

Event Type  Injury  

Event Description

Covidien lp appose ulc slim body skin stapler did not close completely.

• Brand Name: APPOSE ULC
• Type of Device: STAPLE, REMOVABLE (SKIN)
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10754893
• MDR Text Key: 213661571
• Report Number: 10754893
• 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: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8886803712
• Device Catalogue Number: 8886803712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/14/2020
• Date Report to Manufacturer: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 25915 DA