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

Model Number CUSTOM PAK

Device Problems Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/05/2014

Event Type  malfunction  

Event Description

A surgeon reported that during a combined cataract and vitrectomy surgery, the infusion cannula failed to lock into the trocar.After everything had been set up and the cassette had been primed, the surgeon started the surgery by placing the trocar into the eye and then placed the infusion cannula into the trocar.As soon as the infusion pressure was turned on, the infusion cannula popped out of the trocar.In surgeon's opinion, the reason why the infusion cannula could not lock into the trocar was because the silicone layer which covers the base of the infusion cannula was too far forward onto the base of the infusion cannula.A new pak had to be opened and this time the infusion cannula could lock into the trocar.The surgeon could complete the surgery with a delay of twenty minutes.No further information is expected.This is one of four medical device reports being filed for this facility.

Manufacturer Narrative

The sample has been received and in-house evaluation is in progress.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.No further information is expected.(b)(4).This report was mailed to fda on: 07/10/2014.(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: 3998907
• MDR Text Key: 4953773
• Report Number: 1644019-2014-00118
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: CY
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2014
• 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 PAK
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/27/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2014
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: CMB, 23G 5.0CPM VALVED, 0.9
• Patient Age: 77 YR