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

Catalog Number 9597-17

Device Problem Material Frayed (1262)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Event Description

A scrub technician reported that the wek cels have lint on them and the lint is getting on the patient's eye.The lint is being flushed out but in some instances it is retained on the cornea.Additional information and product sample have been requested for this report.

Manufacturer Narrative

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.(b)(4).

Manufacturer Narrative

This is one of two complaints reported for this custom pak lot; however this is the first complaint for this issue for this lot.Review of the device history record indicates the order was built to specification.The product was released based on the manufacturer's acceptance criteria.Ten opened sponge samples in a zip top bag were received for the report of lint.All samples were inspected per facility procedure and all samples were determined to be visually conforming.All visual tests performed during the evaluation were determined to be acceptable based on the visual standards established for the product.A root cause cannot be determined for the complaint as described by the customer.The manufacturer internal reference number is: (b)(4).

Event Description

A scrub technician reported that lint from the weck cells was observed in an unspecified number of patient's eyes during their postoperative examination.

• 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: eddie darton, md, jd ; mail stop ab2-6; mail stop r3-48; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 4663612
• MDR Text Key: 16305886
• Report Number: 1644019-2015-00516
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2017
• Device Catalogue Number: 9597-17
• Device Lot Number: 1694333H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2015
• 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