MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON IDRIVE ULTRA POWERED HANDLE 1; REUSABLE SURGICAL STAPLER

Model Number IDRVULTRA1

Device Problem Crack (1135)

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

Event Date 12/09/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Procedure: sleeve gastrectomy.According to the reporter: reload cracked where it mates with the idrive adapter while attempting to positon the stapler on the stomach for the sixth and final firing for a sleeve gastrectomy.For reports concerning surgical stapling devices, was another manufacturers reinforcement material used? no current patient status: alive, stable, no injury.Did the difficulty result in unintended colostomy, formal laparotomy, re-operation etc.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 patient's cavity and no device fragment left in patient.If applicable, what was done to correct this condition? (be specific e.G.Cautery, sutured, applied another device, etc.) : a manual endo gia and 60 purple trs tri staple reloads were issued and successfully deployed.

Manufacturer Narrative

(b)(4).

• Brand Name: IDRIVE ULTRA POWERED HANDLE 1
• 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: 4366812
• MDR Text Key: 12788517
• Report Number: 1219930-2014-01203
• Device Sequence Number: 1
• Product Code: GDW
• 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: 12/09/2014

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: IDRVULTRA1
• Device Catalogue Number: IDRVULTRA1
• Device Lot Number: N4D1640UX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/09/2014
• Initial Date FDA Received: 12/29/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• 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
• Treatment: PRODUCT NUMBER: EGIAADAPTXL,
• Patient Age: 43 YR
• Patient Weight: 39