MAUDE Adverse Event Report: COVIDIEN ENDO GIA ULTRA UNIVERSAL STAPLER; STAPLER, SURGICAL

Model Number EGIAUXL

Device Problems Connection Problem (2900); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2018

Event Type  malfunction  

Event Description

Physician was doing a bariatric sleeve procedure when using the endo gia ultra universal stapler 12mm xl.The device started clicking and would not engage.There was no pt harm.Device was removed from the field and a new one was opened.

• Brand Name: ENDO GIA ULTRA UNIVERSAL STAPLER
• Type of Device: STAPLER, SURGICAL
• Manufacturer (Section D): COVIDIEN; mansfield MA 02048
• MDR Report Key: 7757190
• MDR Text Key: 116446938
• Report Number: MW5078895
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: EGIAUXL
• Device Lot Number: P8E0029X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2018
• Is the Reporter a Health Professional?: Yes
• 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