MAUDE Adverse Event Report: MEDTRONIC / COVIDIEN GIA STAPLER; STAPLER, SURGICAL

Lot Number P9B1563KY

Device Problem Failure to Form Staple (2579)

Patient Problem Failure to Anastomose (1028)

Event Date 07/09/2019

Event Type  malfunction  

Event Description

Gia 60mm stapler ref# gia6038s, lot# p9b1563ky fired but did not securely staple bowel together.Dr (b)(6) had to re-cut and re-staple bowel.Charge nurse given product sticker with catalog and lot numbers.Fda safety report id# (b)(4).

• Brand Name: GIA STAPLER
• Type of Device: STAPLER, SURGICAL
• Manufacturer (Section D): MEDTRONIC / COVIDIEN
• MDR Report Key: 8793330
• MDR Text Key: 151297726
• Report Number: MW5088121
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: P9B1563KY
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 46 YR