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

Model Number EGIAADAPTXL

Device Problems Sticking (1597); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/04/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The catalog#, model# and brand name were corrected.

Event Description

Procedure: sleeve gastrectomy.According to the reporter: this happened while an experienced staff and surgeon were using i-drive on a sleeve gastrectomy.As you can see from the photo after the reload was removed from the adapter the removal switch was stuck.This caused the adapter and reload to come in and out of contact resulting in auto articulations outside the patient on the back table.There was no patient complications and the surgeon used a manual xl adapter to finish the last firing of the case.This adapter will be sent back.The black reload removal switch is stuck.It seems to be jammed.A manual xl adapter was used to finish the procedure.The idrive handle and adapter worked fine for 4 or 5 firings and experienced this malfunction after the second to last reload was removed.Once the surgical tech removed the reload and loaded a new one, the adapter would not recognize the reload.The reload then experienced an auto articulation outside the pt on the back table because, the removal button is stuck.There was no unanticipated tissue loss.There was no unanticipated tissue damage.There was no unanticipated extension for the incision more than one inch.There was no unanticipated blood loss of more than 500cc.There was no delay over 30 minutes.No device fragment fell in the patient cavity.No device fragment was left in the patient.Other manufacturer's reinforcement material was used: seamguard.

Manufacturer Narrative

(b)(4).

• Brand Name: ENDO GIA ADAPTER XL
• Type of Device: REUSABLE STAPLING PRODUCT
• 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: 4121196
• MDR Text Key: 12855265
• Report Number: 1219930-2014-00888
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2014
• 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
• Device Lot Number: N4G0466ULX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• 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