MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC PREMIUM SURGICLIP* II M-11.5 TITANIUM; DISPOSABLE CLIP APPLIER

Model Number 134053

Device Problems Device Difficult to Setup or Prepare (1487); Failure to Form Staple (2579); Device Operates Differently Than Expected (2913)

Patient Problem Tissue Damage (2104)

Event Date 04/07/2015

Event Type  Injury  

Event Description

Procedure: liver transplant.According to the reporter: the clips failed to load in the jaw of the applicator after two to three successful applications of the clips.Because of the instrument failure, the surgeon is more concerned about the vessel damage it had caused.The first four clips formed correctly but after that the clip got stuck in the jaw.The tissue damage was not complicated.There was no tissue loss, blood loss or extension of or time.The current patient status is fine.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).

• Type of Device: DISPOSABLE CLIP APPLIER
• Manufacturer (Section D): COVIDIEN, FORMERLY USSC PUERTO RICO INC; building 911-67; sabanetas industrial park; ponce PR 00731
• Manufacturer (Section G): COVIDIEN, FORMERLY USSC PUERTO RICO INC; building 911-67; sabanetas industrial park; ponce PR 00731
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 4702185
• MDR Text Key: 5717909
• Report Number: 2647580-2015-00283
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K853650
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: 134053
• Device Catalogue Number: 134053
• Device Lot Number: P3K0275X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: PRODUCT ID 134046. LOT NUMBER P4F0525X
• Patient Outcome(s): Other
• Patient Age: 45 YR
• Patient Weight: 55