MAUDE Adverse Event Report: COVIDIEN PREMIUM SURGICLIP S-9.0 TITANIUM; DISPOSABLE CLIP APPLIER

Catalog Number 134046

Device Problems Device Difficult to Setup or Prepare (1487); Failure to Form Staple (2579); Difficult to Advance (2920); Mechanical Jam (2983)

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

Event Date 01/17/2014

Event Type  Injury  

Event Description

Procedure: breast reconstruction.According to the reporter: clips not loading into jaw.Jamming.Clips are severing vessels.Clips are criss crossing.No unanticipated tissue loss.No extension of the incision.No blood loss greater than 500cc.No extension of surgery time.No fragment fell into the patient.

Manufacturer Narrative

(b)(4).

• Brand Name: PREMIUM SURGICLIP S-9.0 TITANIUM
• Type of Device: DISPOSABLE CLIP APPLIER
• Manufacturer (Section D): COVIDIEN; building 911-67; sabanetas industrial park; ponce PR 00731
• Manufacturer (Section G): COVIDIEN; building 911-67; sabanetas industrial park; ponce PR 00731
• Manufacturer Contact: sharon murphy, qa ; 60 middletown avenue; north haven, CT 06473 ; 2034925267
• MDR Report Key: 3625060
• MDR Text Key: 4133771
• Report Number: 2647580-2014-00065
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K853650
• 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: 01/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 134046
• Device Lot Number: P3L0210X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other