MAUDE Adverse Event Report: USSC PUERTO RICO, INC. PREMIUM SURGICLIP S-9.0 TITANIUM; DISPOSABLE CLIP APPLIER

Catalog Number 134046

Device Problems Bent (1059); Appropriate Term/Code Not Available (3191)

Patient Problem Tissue Damage (2104)

Event Type  Injury  

Event Description

Procedure: av fistula.According to the reporter: the clips were already bent closed prior to being fired as per the staff.Device shredded vessels.There was no unanticipated tissue loss.The incision was not extended by more than one inch.There was no unanticipated blood loss of 500 cc or more.Surgery time was not delayed by more than 30 minutes.No device 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): USSC PUERTO RICO, INC.; 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 ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 3716179
• MDR Text Key: 4333402
• Report Number: 2647580-2014-00207
• 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: 03/07/2014

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2014
• Initial Date FDA Received: 03/25/2014
• 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
• Patient Outcome(s): Other