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

Model Number CUSTOM PAK

Device Problems Leak/Splash (1354); Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/13/2014

Event Type  malfunction  

Event Description

A nurse reported that during a pars plana vitrectomy and membranectomy with retinal detachment repair procedure, the trocar canula was leaky and it was difficult to remove the soft tip without the trocar coming out with the instrument.The trocar was replaced with a standalone valved entry system to complete the case.There was no harm to the patient.No sample is available as the customer discarded the product.No further information is expected for this case.

Manufacturer Narrative

No samples were returned for evaluation; therefore, the condition of the product could not be verified.A lot number was not indicated for this complaint; therefore, the device history record (dhr) for the lot could not be reviewed for abnormalities that could have contributed to the complaint.Because a sample was not returned and no lot number was indicated for this complaint, the root cause cannot be determined.No further information is expected for this case.(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 south freeway, r3-48; fort worth, TX 76134 ; 8176152742
• MDR Report Key: 3957372
• MDR Text Key: 4612571
• Report Number: 1644019-2014-00110
• 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: Other
• Type of Report: Initial
• Report Date: 05/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2014
• 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 APK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/21/2014
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: TOTAL PLUS PAK 25+5000 CUTS PER MIN VALVE STD
• Patient Age: 25 YR