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

Catalog Number 8065752193

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Discharge (2225)

Event Date 01/28/2016

Event Type  malfunction  

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).

Event Description

A nurse reported to a company representative that the sleeves received are smaller than those typically received and when using the sleeve in combination with a 2.75 millimeter blade, this makes the wound leak.A second bottle of viscoelastic was used due to the resulting leak.Additional information and product sample have been requested.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Event Description

Additional information was received which indicated that the facility received incorrect sleeves and tips.The product was used and during the procedure the basic salt solution (bss) exited the wound since the seal was slightly smaller than what their 2.75 millimeter blade and console settings were adjusted for.An extra 50 millimeters of bss was used to mediate the issue.The procedures were completed without patient harm.

Manufacturer Narrative

The lot specific to this event is not known; therefore, lot history and device history record (dhr) reviews are not possible.The customer reported that they had been receiving orange infusion sleeves as opposed to purple sleeves.A product review was conducted and it was found that the reported incorrect product should contain a small parts tray which has an orange infusion sleeve.Initially, it was suspected that the (b)(4) warehouse made a picking error and sent the wrong product; however, upon further investigation by (b)(4) qa, it was determined that the customer actually ordered the product reported to be incorrect.The root cause of this customer's complaint are two orders placed by the customer in which the customer unknowingly ordered the incorrect product.Action will not be taken for this occurrence as the root cause is a customer error.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.Consumables manufacturing management has been made aware of this complaint through the (b)(6) review meeting.(b)(4).

• Brand Name: CENTURION SURGICAL PROCEDURE PAK
• 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: 5451297
• MDR Text Key: 38692444
• Report Number: 1644019-2016-00394
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 06/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065752193
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2016
• Initial Date FDA Received: 02/22/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/08/2016; 06/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: UNSPECIFIED BLADE, 2.75 MM
• Patient Outcome(s): Other; Required Intervention