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

Model Number CUSTOM PAK

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/22/2014

Event Type  malfunction  

Event Description

A customer reported that when the surgeon attempted to remove the fiber optic during a vitrectomy procedure, the trocar cannula got stuck on the probe and came out of the eye with the fiber optic.During the same case, the same issue occurred with the same issue occurred with the curved laser probe.Between the two probes, the issue happened about three times.Each time, the surgeon reinserted the trocar and continued with surgery.There was no harm to the patient.Clarification has been requested as one of the returned products differs from that which was reported by the customer.This is the first of two reports for this case.

Manufacturer Narrative

The investigation is in progress.Samples have been received for evaluation.The device history records (dhr) for the lots were reviewed.No abnormalities that could have contributed to the customer complaint issues were found during the dhr review and the product was released according to the manufacturer's acceptance criteria.A root cause has not been identified.Additional info has been requested.(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: 3949195
• MDR Text Key: 4601984
• Report Number: 1644019-2014-00079
• 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: Other
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/03/2014

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 Expiration Date: 05/31/2015
• Device Model Number: CUSTOM PAK
• Device Catalogue Number: CUSTOM PAK
• Device Lot Number: 1540975H
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/03/2014
• Initial Date FDA Received: 05/01/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2013
• 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: 25GA ILLUM FLEX CURV LASER PROBE; TOTAL PLUS PAK, 25+ 5000 CUTS PER MINUTE STD
• Patient Age: 45 YR