MAUDE Adverse Event Report: COVIDIEN LP ENDO GIA ULTRA UNIVERSAL STAPLER; STAPLE, IMPLANTABLE

Model Number EGIAUSTND

Device Problems Mechanical Problem (1384); Difficult to Open or Close (2921)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/17/2022

Event Type  malfunction  

Event Description

Md was attempting to use endo gia stapler for appendectomy.Stapler would not stay close when attempted to fire.A new load was opened and loaded on stapler and placed on appendix and again stapler was closed and fire button was pressed and stapler would not stay closed to fire load.This was tried outside of the patient as well and stapler appeared to be faulty.A new stapler was opened and appendectomy was completed without any further issues.

• Brand Name: ENDO GIA ULTRA UNIVERSAL STAPLER
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 15319402
• MDR Text Key: 298888110
• Report Number: 15319402
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EGIAUSTND
• Device Lot Number: P2C0942
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/23/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/30/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 16060 DA
• Patient Sex: Female