MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC GIA 60-3.8 SINGLE USE LOADING UNIT; DISPSOABLE SURGICLA STAPLING DEVICE

Catalog Number GIA6038L

Device Problems Cut In Material (2454); Failure to Form Staple (2579)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/28/2014

Event Type  Injury  

Event Description

Procedure type: colectomy.According to the reporter: tech left used reload in gia and surgeon was able to fire it again with no stapling but with cutting colon causing an extra hour of work to fix.Current pt status: fine what was done to correct this condition: suture and cautery.There was no unintended colostomy, formal laparotomy, re-op, etc.The incision was extended by more than one inch.There was no unanticipated blood loss of 500cc or more.Surgery time was delayed by more than 30 minutes but did not affect the pt in any way such as extension of the hospital stay.No device fragment fell into the pt and no fragment was left in the pt.No reinforcement material was used.

Manufacturer Narrative

(b)(4).

• Brand Name: GIA 60-3.8 SINGLE USE LOADING UNIT
• Type of Device: DISPSOABLE SURGICLA STAPLING DEVICE
• Manufacturer (Section D): COVIDIEN, FORMERLY USSC; building 911-67; ponce PR 00731
• Manufacturer (Section G): COVIDIEN, FORMELRY USSC PUERTO RICO; building 911-67; sabanetas industrial park; ponce PR 00731
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 3732998
• MDR Text Key: 4325066
• Report Number: 2647580-2014-00215
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013860
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: GIA6038L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2014
• 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
• Patient Outcome(s): Other