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

Catalog Number 8065752060

Device Problems Failure to Cut (2587); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/26/2018

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

Event Description

An ophthalmic surgeon reported that the cutter did not actuate from the beginning of using it although test was passed.Cutting failure also occurred.The condition of aspiration was unknown.The surgery was completed after replacing the probe with another one.There was no patient harm.

Manufacturer Narrative

A review of the related device history records for 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 for the reported issue.One opened probe was received for evaluation.The returned sample was visually inspected and found conforming.Aspiration testing was performed and found conforming.Actuation testing was performed and found non-conforming.Cut testing was performed and was found non-conforming.The probe was disassembled and the components inspected.There is excessive 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, cutting edge, and at several locations along the inner cutter.The inner cutter pulled out of the coupling.The fillet of adhesive is on the inner cutter.Upon further inspection of the adhesive fillet it was found to be the correct amount and correct type of adhesive.The complaint evaluation does confirm the probe had actuation and cut issues.The most likely contributing factor to these issues is the separation of components within the probe.It appears that during surgical use the adhesive bond failed causing the inner cutter to detach from the coupling.A second contributing factor to the actuation and cut issues is the excessive surgical use of the probe.The vitrectomy portion of the procedure is typically less than 20 minutes and it appears that the probe had experienced a use much greater than this typical timeframe.The excess usage of the probe will wear and damage the inner cutter such that the cutter function becomes poor, bent, or does not function at all.An investigation has been completed and actions have been implemented to lower the frequency of probe complaints due to the detachment of the inner cutter from the coupling and to reduce the frequency of probe complaints.The procedure was also reviewed and found to provide adequate instructions to operators for the bonding process of the inner cutter to coupling.Probes continued to be 100% inspected for actuation, aspiration, and cut during manufacturing.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No additional action is required at this time.(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: 7352308
• MDR Text Key: 103020989
• Report Number: 1644019-2018-00060
• 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: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 8065752060
• Device Lot Number: 2048110H
• Other Device ID Number: 380657520602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other