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

Catalog Number 8886803712

Device Problems Sticking (1597); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/02/2014

Event Type  malfunction  

Event Description

The patient underwent excision and primary closure of the basal cell carcinoma of the left parietal scalp, excisional biopsy of right pinna lesion, and co2 laser ablation of multiple actinic keratosis of left malar eminence.During the surgery, the stapler was being used when it locked up and would stick during use.A second stapler was then used and had the same issue.Both staplers had same lot and reference numbers.There was no delay or harm to patient.

• Brand Name: APPOSE
• Type of Device: STAPLE, REMOVABLE (SKIN)
• Manufacturer (Section D): COVIDIEN; 15 hampshire street ; mansfield MA 02048
• MDR Report Key: 3800015
• MDR Text Key: 4365999
• Report Number: 3800015
• Device Sequence Number: 1
• Product Code: GDT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 8886803712
• Device Lot Number: J3K02031X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/23/2014
• Event Location: Hospital
• Date Report to Manufacturer: 05/08/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OCCURRED DURING SURGERY
• Patient Age: 76 YR
• Patient Weight: 75