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

Catalog Number AS11912-17

Device Problem Dull, Blunt (2407)

Patient Problem Tissue Damage (2104)

Event Type  malfunction  

Manufacturer Narrative

A product sample was received and it is awaiting evaluation.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).

Event Description

A nurse reported that the substitute blades are not as sharp, have burs and are wider which reportedly resulted in jagged incisions.The facility reports exchanging the blade to complete the procedures.Additional information and product sample have been requested.

Manufacturer Narrative

This is the first complaint reported for this finished goods lot.Review of the device history record indicates the order was built to specification.One unopened blade was returned for this complaint.Visual inspection of the knife in the lab was unable to confirm the customer's complaint of a dull blade.The sample was sent to the supplier so that a thorough investigation of the blade could be performed.Though the definitive root cause could not be determined in the lab, the most likely root cause of the customer's complaint of unacceptable, dull blades is an error that occurred during the supplier's manufacturing process.The root cause of the customer¿s dissatisfaction with the knife substitution is due to a temporary deviation which occurred due to a backorder with the supplier.During the backorder, a substitute knife was approved for use.Quality engineering materials has notified the supplier and sent the sample for further investigation.Quality assurance will continue to monitor and take action for any future occurrences as is deemed necessary.(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: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5529000
• MDR Text Key: 41277851
• Report Number: 1644019-2016-00568
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: AS11912-17
• Device Lot Number: 1844213H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2016
• 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