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

Catalog Number 8065752918

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

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

Event Date 07/20/2016

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 customer reported that the sleeves are too big.The reporter stated that "more torque is needed to the get the instruments through the incision." additional information has been requested for this event.A product sample has been requested for evaluation.

Manufacturer Narrative

(b)(4).

Event Description

No harm was reported in the initial report.

Manufacturer Narrative

The lot specific to this event is not known; therefore, lot history and device history record reviews is not possible.Six purple 0.9mm slick infusion sleeves were returned for evaluation.The sleeves were visually inspected and the texture on the inner wall of the shafts and tips was intact.The inner diameters of the sleeves were within specification.No twist was observed on any of the samples when the twist test was performed.The sleeves were varying shades of purple; however the sleeves were compared with the drawing and were within the specified color range.This customer's complaint is most likely due to the slight color variation between the sleeves produced by the two suppliers; however, all of the returned sleeves met specifications.After a thorough investigation of this complaint, it has been determined that the returned samples met specifications; therefore, no action will be taken at this time.In addition one opened knife was received with a foam tip protector in a zip top bag for the report of blade size issue.The sample was visually inspected and was found to be conforming.A dimensional inspection was then performed and was also conforming.No lot number was identified with this complaint; therefore, lot history and complaint history reviews could not be conducted.The returned sample was found to be conforming, therefore a blade size issue as described in the complaint was not confirmed and a root cause cannot be determined for the complaint as described by the customer.(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: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 5866201
• MDR Text Key: 52492284
• Report Number: 1644019-2016-01104
• 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: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065752918
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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