MAUDE Adverse Event Report: COVIDIEN ENDO GIA ULTRA STAPLER 60MM; GIA STAPLER

Model Number 030457

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/24/2017

Event Type  malfunction  

Event Description

Urologist reports that the device was inserted to staple the renal artery and reports it would not clamp down.Hand-assisted laparoscopic left radical nephroureterectomy that was converted to open.No apparent harm to pt.Device returned to covidien for quality inspection.

• Brand Name: ENDO GIA ULTRA STAPLER 60MM
• Type of Device: GIA STAPLER
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 6770569
• MDR Text Key: 82043395
• Report Number: MW5071389
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 08/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: 030457
• Device Lot Number: N7C0369KX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/03/2017
• 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: 78 YR