MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HOUSTON CUSTOM-PAK SURGICAL PROCEDURE PACK; GENERAL SURGERY TRAY (KIT)

Catalog Number AS6077-69

Device Problems Partial Blockage (1065); Detachment Of Device Component (1104); Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/18/2017

Event Type  malfunction  

Manufacturer Narrative

A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.(b)(4).

Event Description

A surgeon reported the joining of the hydro-dissection cannula and a 2.5 milliliter syringe was weak and the hydro cannula would become detached by water pressure during a procedure.The procedure was completed after replacing the a pack with another one.The surgeon indicated the loosening was not caused by blockage since he/she checks the cannula to see if blockage occurred though the same hydro cannula that is used for both hydro-dissection and intraocular adjustment at the final stage of the procedure.There was no harm to the patient and there is no sample to return.No additional information is expected.

Manufacturer Narrative

This is the third complaint reported for this finished goods lot; however the second for this issue.A review of the device history record (dhr) indicates the order was built to specification.Samples were not returned.With no samples received, visual inspection or functional testing could not be conducted of the cannula or the syringe.An investigation was performed by the supplier of the syringe.Although no sample was returned to the supplier site, syringes from the same lot as the reportedly affected product were tested to attempt to replicate the customer's reported failure mode.Three samples were visually and functionally inspected with another hydro cannula and the syringe met jis (japanese industrial standards) specifications.The root cause of the customer's complaint is not known; samples were not returned for investigation.Tested samples from the same lot as the one from the customer's complaint met specifications.After a thorough investigation of this complaint, it has been determined that no action will be taken at this time as a sample was not returned.Quality assurance will continue to monitor customer complaints via the complaint review meetings, and will take action for any future occurrences as is deemed necessary.The manufacturer internal reference number is: (b)(4).

• Brand Name: CUSTOM-PAK SURGICAL PROCEDURE PACK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LTD. - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer (Section G): ALCON RESEARCH, LTD. - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 6773931
• MDR Text Key: 82601384
• Report Number: 1644019-2017-00661
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: AS6077-69
• Device Lot Number: 1972994H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2017
• 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
• Patient Outcome(s): Other