MAUDE Adverse Event Report: COVIDIEN ENDO GIA ULTRA UNIVERSAL STAPLER 12MM; STAPLER, SURGICAL

Model Number REF: EGIAUSTND

Device Problem Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/16/2018

Event Type  malfunction  

Event Description

When the surgeon went to use a stapler during surgery, he heard a crunching sound.The surgeon stopped using the stapler and removed it from the operative field.No pt harm / injury occurred during this event.Dates of use: (b)(6) 2018.

• Brand Name: ENDO GIA ULTRA UNIVERSAL STAPLER 12MM
• Type of Device: STAPLER, SURGICAL
• Manufacturer (Section D): COVIDIEN ; mansfield MA 02048
• MDR Report Key: 7805423
• MDR Text Key: 118092340
• Report Number: MW5079289
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• 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: REF: EGIAUSTND
• Device Lot Number: P8E1395X/P8F1402X
• Was Device Available for Evaluation?: Yes
• 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: 67 YR
• Patient Weight: 67