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); Difficult to Remove (1528); Failure to Advance (2524); Failure to Form Staple (2579); Difficult to Open or Close (2921); Mechanical Jam (2983)

Patient Problem Tissue Damage (2104)

Event Date 01/14/2014

Event Type  Injury  

Event Description

Procedure type: cardiac bypass.According to the reporter: customer informs that clips got jammed in one device; they opened another one from the same lot and the same thing happened, then opened 3rd one and the clip did not form correctly.The clip was engaged in the device; the first instrument could not be loaded.On the third device, the jaws could not be opened to removed it from tissue.An electrosurgical pencil was used to cut the tissue.There was no bleeding, and no noticeable delay.

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 ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 3736054
• MDR Text Key: 4277264
• Report Number: 2647580-2014-00232
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K853650
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 134046
• Device Lot Number: P3G0475X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other