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

Catalog Number 8065751617

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/18/2018

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 observed a burr on the vitrectomy probe during a procedure.The product was replaced and procedure completed with no patient harm.

Manufacturer Narrative

Additional information provided.A review of the device history records traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.A complaint history examination indicates there are no additional complaints associated with the lot for the reported issue.One opened probe was received and visually inspected and found non-conforming.There was raised adhesive on the needle and an excessive burr present on the port face cutting edge.The burr observed on the port face, upon closer inspection, was loose foreign material and could be wiped away with an alcohol swab.The adhesive observed on the needle appears to be pushed as if the needle had gone through the trocar.Actuation and cut testing was performed and found non-conforming.The cutter was not seen.Aspiration testing was performed and found conforming.The probe was disassembled and the components inspected.There is approximately 15 minutes of usage wear on the inner cutter when compared to the degree of wear based on continuous actuation of the probe visual standard photos.Gouge marks were observed at the bend area and several locations along the inner cutter.Heavy gouging was observed at the cutting edge of the inner cutter.The disassembled probe was re-tested for actuation and it was found conforming.The complaint evaluation does not confirm that the probe has a burr on the port face; however, there was raised adhesive on the needle that appeared to be pushed, which could have appeared to have been a burr to the end user of the product.Adhesive is used on the needle/needle holder bond and the needle holder/shell bond.During the adhesive application process, it is possible that adhesive could get on the probe needle.In this case, the adhesive was not wiped off of the probe needle and was not caught by downstream inspection.The complaint evaluation also confirms the probe did not actuate or cut to specification in the condition the sample was received.The root cause for these non-conformances cannot be determined from this evaluation.The mostly likely cause for the poor actuation and cut is from interference between the inner cutter and the outer needle that occurred during its approximately 15 minutes of the probe being used.This interference can be due to foreign material or other components within the probe that become damaged which then can will impede the movement of the cutter shaft.The probe actuation testing was deemed conforming when the probe was disassembled and interference between the cutter and its outer needle was eliminated.The heavy gouge marks at the bend area and several locations along the inner cutter is also evidence of inference present during the probe being used.A photo of the non-conforming probe was shown to all assembly personnel to make them aware of the issue.All probes are 100% visually inspected for adhesive on needles and tested for actuation, aspiration, and cut during manufacturing.Any adhesive found on needles is wiped off of the needles.Any other non-conformances found are removed from the lot and scrapped.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No additional action is required at this time.The manufacturer internal reference number is: (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: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7326899
• MDR Text Key: 102194405
• Report Number: 1644019-2018-00046
• 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: health professional,other
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: 8065751617
• Device Lot Number: 2090924H
• Other Device ID Number: 380657516179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2017
• 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