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

Device Problem Entrapment of Device (1212)

Patient Problem No Code Available (3191)

Event Date 06/02/2020

Event Type  Injury  

Event Description

Additional procedure required to removed failed stapler load line from pt.Failure of stapler while in use for pt having acute appendectomy.After stapler line was fired across the appendix base, there appeared to be a retained part of the covidien endo-gia stapler consistent with the endo-gia staplers plastic stapler's deployment tray.Fb successfully removed by re-firing an ethicon stapler across the appendix base.

• Brand Name: COVIDIEN ENDO-GIA STAPLER
• Type of Device: STAPLER, SURGICAL
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 10442160
• MDR Text Key: 204207619
• Report Number: MW5096190
• 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: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 44 YR