MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON ENDO GIA ADAPTER XL; REUSABLE SURGICAL STAPLER

Model Number EGIAADAPTXL

Device Problems Mechanical Problem (1384); Noise, Audible (3273)

Patient Problems Hemorrhage/Bleeding (1888); Tissue Damage (2104)

Event Date 10/28/2014

Event Type  malfunction  

Event Description

Procedure: sleeve gastrectomy.According to the reporter: during fire sequence, there was a popping noise in shaft and stopped mid-fire, just half way through the staple line.After removing device, shaft would only articulate one to the left, but when articulated to right, motor inside idrive ultra would just run without any action from the reload.The egiaadapt was put onto the device to determine if it were the handle or adapter, it was concluded that egiaadaptxl was the issue, while short handle worked fine.List any other products used with device: idrvultra1 was the device used in patient: yes was there patient injury/hazard: no there was no unanticipated tissue loss, no unanticipated extension of incision more than 1 inch, no unanticipated blood loss of more than 500cc and no delay over 30 minutes.No device fell in patients cavity and no device fragment left in patient.

Manufacturer Narrative

(b)(4).

• Brand Name: ENDO GIA ADAPTER XL
• Type of Device: REUSABLE SURGICAL STAPLER
• 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: 4266398
• MDR Text Key: 5296748
• Report Number: 1219930-2014-01074
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/28/2014

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: EGIAADAPTXL
• Device Catalogue Number: EGIAADAPTXL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2014
• Initial Date FDA Received: 11/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1