MAUDE Adverse Event Report: COVIDIEN 12MM XL ENDO GIA UNIVERSAL STAPLER

Model Number EGIAUXL

Device Problems Misfire (2532); Noise, Audible (3273)

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

Event Type  Injury  

Event Description

During a lap.Sleeve gastrectomy, the stapler was fired once successfully, then reloaded with a 60mm purple load and fired again, during the firing it made a loud cracking noise and misfired.A new stapler and load were obtained to continue the procedure.Is the product compounded: no.Is the product over-the-counter: no.

• Brand Name: 12MM XL ENDO GIA UNIVERSAL STAPLER
• Type of Device: STAPLER
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 6597575
• MDR Text Key: 76249338
• Report Number: MW5070044
• Device Sequence Number: 1
• Product Code: GAG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: EGIAUXL
• Device Lot Number: P6L0388X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/25/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Weight: 129