MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC 5.5MM SHORT SECONDARY PORT; DISPOSABLE SURGICAL ACCESS DEVICE

Model Number 24055

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)

Patient Problems Hemorrhage/Bleeding (1888); Complaint, Ill-Defined (2331); Device Embedded In Tissue or Plaque (3165)

Event Date 01/22/2015

Event Type  Injury  

Event Description

Procedure: varicocelectomy.According to the reporter: inserting the port was not easy due to tough skin and fascia.Upon removal of the port it was noticed that a piece of one of the flange has broken off.They looked for it visually with the lap scope as well as taken an x-ray afterwards, it could not be found.Blood loss was less than 500cc and the surgical time extended was +/- 15min.Should additional information be received, a supplemental will be submitted.

Manufacturer Narrative

(b)(4).

• Brand Name: 5.5MM SHORT SECONDARY PORT
• Type of Device: DISPOSABLE SURGICAL ACCESS DEVICE
• 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: 4472771
• MDR Text Key: 5325241
• Report Number: 2647580-2015-00072
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K981941
• 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
• Report Date: 01/23/2015

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: 09/30/2017
• Device Model Number: 24055
• Device Catalogue Number: 24055
• Device Lot Number: P2J0065
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/23/2015
• Initial Date FDA Received: 02/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 23 YR
• Patient Weight: 36