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

Catalog Number 134046

Device Problems Bent (1059); Material Deformation (2976)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/11/2014

Event Type  Injury  

Event Description

According to the reporter: after several firing was done, upon trying to clip the intercostal artery, two clips came out into jaws at the same time.One of those clips fell into the body of patient but it was retrieved.To clip on another side of artery, a doctor fired but no clip was applied on patient with nothing loaded on jaws.However, the doctor cut it without recognizing the failure of clipping by misloading on jaws, and this caused the bleeding.Opened another new surgiclip: product id134046 and found it could be used normally for several clippings.However, later confirmed the malformation of clip that was automatically loaded on jaws: a distal part of the clip was slightly bent in one side.Using the third one, the case was completed.Reported noting improper in operations of the concerning products by the customer.Operating time not extended.

Manufacturer Narrative

(b)(4).

• Brand Name: PREMIUM SURGICLIP S-9.0 TITANIUM
• Type of Device: DISPOSABLE CLIP APPLIER
• Manufacturer (Section D): COVIDIEN, FORMERLY USSC; 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: 3609128
• MDR Text Key: 17955276
• Report Number: 2647580-2014-00058
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K853650
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/15/2014

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 Catalogue Number: 134046
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2014
• Initial Date FDA Received: 01/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1