MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON ENDO GIA* TRI-STAPLE RR 60MM M/T RELOAD; MESH, SURGICAL, DEPLOYER

Model Number EGIATRS60AMT

Device Problems Misfire (2532); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional attempts to obtain information and the device have been made.A supplemental report will be submitted with new details if they become available.

Event Description

According to the reporter, during a gastric bypass, when using the reload to create the pouch, the knife blade stopped 3 times.Had to stop firing and let off the blue button for 30 seconds before continuing the firing.While firing, metal shavings were coming off of the staple load and into the patient.These shavings were removed.The reload was able to fire the full linear length, be removed from the tissue ok, and no problems were observed with the staple line.The procedure time was extended by about 10 minutes to remove the metal pieces.

• Type of Device: MESH, SURGICAL, DEPLOYER
• Manufacturer (Section D): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6190224
• MDR Text Key: 62858369
• Report Number: 1219930-2016-01382
• Device Sequence Number: 1
• Product Code: ORQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133938
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/30/2016

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 Model Number: EGIATRS60AMT
• Device Catalogue Number: EGIATRS60AMT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/30/2016
• Initial Date FDA Received: 12/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: POWERED STAPLER HANDLE AND ADAPTER