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

Catalog Number 8065751904

Device Problem Partial Blockage (1065)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/26/2015

Event Type  malfunction  

Manufacturer Narrative

A sample was received at manufacturing site and in-house evaluation is in progress.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.Additional information has been requested.The manufacturer internal reference number is: (b)(4).

Event Description

A healthcare professional reported that the vitrectome blocked halfway through the procedure.After noticing the defective probe, the procedure was continued with a different probe.There were no negative consequences for the patient and no delay of more than 1 hour.Additional information has been requested.

Manufacturer Narrative

Evaluation summary: one 23ga probe was returned for the probe becoming occluded and stopped working.The probe initially worked fine.For this complaint file, the final customer lot was identified.For this final lot, five component probe lots were used to make up the final lot.A device history record review for each of the five lots was conducted.According to the device history record review, one lot was reprocessed for an anomaly that did not contribute to the customer complaint.No anomaly was found during the device history record reviews for the other four lots.The product was released based on the product¿s acceptance criteria.Aspiration testing was performed and deemed conforming.Actuation and cut testing was performed and deemed nonconforming.The cutter was never observed in the port during testing.The probe was disassembled and the components inspected.There was approximately 15 minutes of usage wear on the inner cutter when compared to the cutter wear visual standards.There was no resistance felt when removing the needle from the inner cutter.There were wear marks at the bend area.The actuation test was repeated after the disassembly of the outer needle and the testing was then deemed conforming.The inner cutter diameter was measured and deemed conforming to insure the correct 23ga cutter needle was used for the probe assembly.The complaint evaluation did confirm the probe stopped working during its use.The evaluation did not confirm the probe was blocked.The probe aspirated to specification.The probe testing indicated both actuation and cut testing were nonconforming.The investigation did indicate the probe initially did actuate and cut for approximately 15 minutes.At some point in its surgical use there appeared to have been some unknown reason that impeded the movement of the inner cutter within the outer tubing.Possible reasons for this interference could be foreign material being wedged between the cutter and needle, the drifting of the cutter bend angle during its use, or the cutter becoming misaligned during its use.The exact reason for this restriction of movement of the cutter cannot be determined from this evaluation, but when the resistance was eliminated by disassembly of the probe outer needle from the cutter, the cutter movement was then good and able to actuate.

• 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: 5376109
• MDR Text Key: 36738936
• Report Number: 1644019-2016-00084
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: Initial,Followup
• Report Date: 04/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: 8065751904
• Device Lot Number: 1791485H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2015
• 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