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

Catalog Number 8065752020

Device Problem Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

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

An ophthalmic doctor indicated that the vitrectomy probe was stuck in the trocar canula during the combined procedure.The problem was resolved after replacing the product with another one.The procedure was completed with no harm to the patient.A product sample has been requested, however, it has not been received for evaluation at the manufacturing site.

Manufacturer Narrative

A device history record review was conducted and no anomalies were a complaint history examination indicates that this is the first complaint for a cutter stuck in trocar received against the components of the reported lot.The sample was visually inspected and was deemed nonconforming.An unknown foreign material is present on the probe needle.The probe needle was inserted into a conforming trocar and was deemed nonconforming.The foreign material was removed from the probe.The probe fit test was then conforming as the needle did insert completely through the trocar.A dimensional inspection was performed on the trocar cannula inner diameter and was found to be conforming.The foreign material may have been a factor that was encountered during the procedure.Particulate such as this could prevent the insertion or withdrawal of devices through the trocar due to the close-fitting relationship of the trocar and the mating device.The mating components of the probe and trocar were determined to be dimensionally conforming, an exact root cause for this event could not be determined.(b)(4).

• Brand Name: CONSTELLATION 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: 4961799
• MDR Text Key: 23396555
• Report Number: 1644019-2015-00788
• 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
• Remedial Action: Other
• Type of Report: Followup
• Report Date: 02/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Catalogue Number: 8065752020
• Device Lot Number: 1734551H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/03/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2015
• 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