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

Catalog Number 8065751767

Device Problem Failure to Cut (2587)

Patient Problems Corneal Abrasion (1789); Corneal Edema (1791); Corneal Ulcer (1796); Retinal Detachment (2047); Retinal Tear (2050); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/10/2022

Event Type  Injury  

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

A physician reported a vitrectomy cutter did not cut with aspiration which led to an iatrogenic tear during the combined cataract vitrectomy procedure.The vitrectomy cutter was changed out with another cutter, however the issue was not resolved and the procedure was aborted.The patient experienced post-operative corneal abscess, corneal edema, retinal detachment, sequelae of incomplete macular peeling and epithelial degradation.The procedure was scheduled next day and it was observed there were several surgical variables that contributed to the reported events.The patient was hospitalized because he was demented and it was impossible to administer the treatment of corneal edema induced by the various pre-operative inconveniences.This is one of the two reports.

Manufacturer Narrative

One opened probe was received, without tip protector, in a tray along with other items.At the time of receipt, the probe needle was observed to be bent and it was noted that the tubes was cut off.The sample was visually inspected and found to be nonconforming with the probe needle bent at the stiffener, confirming the received condition.The inner cutter was in the port and clear foreign material was observed on the port face and on the inner cutter.The sample was then functionally tested for actuation, aspiration and cut.The sample was found to be nonconforming for actuation and aspiration.The cut functionality of the returned probe was unable to be tested due to the actuation failure.The probe was disassembled and the components inspected.No/minimal wear observed on inner cutter when compared to the degree of wear based on continuous actuation of the probe visual standard photos.Inner cutter was observed to be severely bent.Inner cutter pulled out of the coupling, the fillet was deemed conforming.No presence of adhesive observed on the inner cutter.A review of the device history record traceable to the reported lot number, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.The complaint confirms the probe had an aspiration failure.The evaluation also indicates the probe had an actuation failure.The cut functionality of the returned probe was unable to be tested due to the actuation failure.However, the observed actuation failure would have led to the reported cut failure.The cause of the observed aspiration failure is the inner cutter remaining in the port of the probe needle due to the actuation failure, obstructing aspiration flow through the probe.The root cause for the observed actuation failure 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.An internal investigation was completed and additional controls within the manufacturing process have been implemented to reduce the frequency of probe complaints for detachments of the inner cutter from the coupling.The procedure was reviewed and found to provide adequate instructions to operators for the bonding process of the inner cutter to coupling.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.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, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer (Section G): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 13313327
• MDR Text Key: 284168305
• Report Number: 1644019-2022-00070
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657517671
• UDI-Public: 00380657517671
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 8065751767
• Device Lot Number: 2515117H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CONSTELLATION SURGICAL PROCEDURE PAK.; CONSTELLATION VISION SYSTEM.; CONSTELLATION VISION SYSTEM.
• Patient Outcome(s): Other
• Patient Age: 85 YR
• Patient Sex: Male