MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO PREMIUM SURGICLIP* S-9.0 TITANIUM; DISPOSABLE CLIP APPLIER

Catalog Number 134046

Device Problems Bent (1059); Failure to Form Staple (2579)

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

Event Date 03/18/2014

Event Type  Injury  

Event Description

Procedure type: cardiac surgery.According to the reporter: customer informs that the clips did not form correctly: they came out bent or di not close completely.When doing the artery graft the clip tore the artery and there was a hemorrhage (less than 250 cc) which was quickly controlled suturing manually (prolene 7/0) and manual ligation.Some clips fell in the patients cavity and were easily removed as being an open surgery.More than 30 minutes delay.

Manufacturer Narrative

(b)(4).

• Type of Device: DISPOSABLE CLIP APPLIER
• Manufacturer (Section D): COVIDIEN, FORMERLY USSC PUERTO RICO; building 911-67; ponce PR 00731
• Manufacturer (Section G): COVIDIEN, FORMERLY USSC PUERTO RICO; building 911-67; sabanetas industrial park; ponce PR 00731
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 3763327
• MDR Text Key: 4465629
• Report Number: 2647580-2014-00255
• 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: 03/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: P3L0093X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2014
• Initial Date FDA Received: 04/08/2014
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other