MAUDE Adverse Event Report: ALCON - HOUSTON CUSTOM PAK; CONVENIENCE KIT

Model Number CUSTOM PAK

Device Problem Fitting Problem (2183)

Patient Problem No Information (3190)

Event Date 02/01/2014

Event Type  malfunction  

Event Description

A nurse reported problems with light pipes and cutters running through the trocar cannulas.Attempts have been made for further info and pt involvement for this case.No updates have been received.

Manufacturer Narrative

Multiple attempt has been made to obtain add'l event details for this report.No updates have been received.The investigation is still in process.No samples were returned for eval, therefore, the condition of the product could not be verified.Product history records could not be reviewed because the reporter did not provide a lot number or any identification traceable to the manufacturing documentation.Because a sample was not returned and no lot number was provided, the root cause for the light pipe not fitting through trocar cannot be determined.(b)(4).

• Brand Name: CUSTOM PAK
• Type of Device: CONVENIENCE KIT
• Manufacturer (Section D): ALCON - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer (Section G): ALCON - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: janet moran ; 6201 s freeway; r3-48; fort worth, TX 76134 ; 8176152742
• MDR Report Key: 3815640
• MDR Text Key: 4504588
• Report Number: 1644019-2014-00053
• Device Sequence Number: 1
• Product Code: KYG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CUSTOM PAK
• Device Catalogue Number: CUSTOM PAK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2014
• Initial Date FDA Received: 03/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1