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

Catalog Number 8065752022

Device Problem Device Operates Differently Than Expected (2913)

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 surgeon reported that the vitrectomy probe did not actuate in the middle of surgery.The condition of aspiration is unknown.The product was replaced and the procedure was completed.There was no patient harm.

Manufacturer Narrative

A review of the device history record 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.The sample was visually inspected and was found to be conforming.The sample was functionally tested for actuation, aspiration and cut and was found conforming for actuation and cut and non-conforming for aspiration.The probe was disassembled and the components inspected.There was approximately 10 minutes of wear on inner cutter when compared to the degree of wear based on continuous actuation of the probe visual standard photos.Wear marks were observed at the cutting edge and bend area of the inner cutter.The sample was tested with a syringe and resistance was felt.A wire was inserted through the aspiration path to remove the blockage.The sample was retested with a syringe and no resistance was felt.The sample was retested for aspiration with the probe driver and the test was found conforming.The initial aspiration test failed due to a blockage in the aspiration path and once the blockage was removed the probe then functioned properly.The returned sample was found to be functionally conforming for actuation, therefore an actuation failure as described in the complaint was not confirmed and a root cause cannot be determined for the complaint as described by the customer.Unrelated to the reported event, the sample evaluation results indicated that the probe had an aspiration issue.The root cause of the aspiration issue cannot be determined from this evaluation.The most likely contributing factor to the aspiration issue is foreign material introduced during the time the probe was in use.No action was taken as the probe was manufactured to specifications.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No further actions are required.(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: 7352344
• MDR Text Key: 103015794
• Report Number: 1644019-2018-00061
• 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
• 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: 09/30/2019
• Device Catalogue Number: 8065752022
• Device Lot Number: 2079120H
• Other Device ID Number: 380657520220
• 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: 05/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2017
• 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