MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER CONSTELLATION VISION SYSTEM; UNIT, PHACOFRAGMENTATION

Model Number TABLETOP-JAPAN

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/13/2018

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

A surgeon reported the tip of probe broke and detached during a retinal detachment procedure.The detached part of the probe was removed during the same session.The total time of the use of the probe was less than 10 minutes.The customer realized the broken tip because aspiration was performed though cutting could not be performed when he was treating the peripheral part.The procedure was completed after replacing the probe with another one.There was no harm to the patient.No additional information is expected.

Manufacturer Narrative

One opened probe was received with a tip protector in a tray for the report of broken and detached tip of probe.The tip of the probe was received in a petri dish.A universal serial bus (usb) drive was also returned.Two photos of the probe needle are attached to the parent file.The photos were reviewed by the manufacturing site.The first photo provided by the affiliate shows the probe needle broken at the port.The second photo provided by the affiliate shows the detached tip of the probe.The photos confirm the reported malfunction.A video of the surgical procedure was returned to the manufacturing site.The video was reviewed by the manufacturing site.The video shows the probe needle tip fell into the eye and was retrieved.The manufacturing site is unable to determine the total cutter actuation time.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 two additional complaints associated with the lot for the reported issue.The returned sample was visually inspected and was found non-conforming with a bent needle and the probe needle broken at the port.The probe was disassembled and the components inspected.Excessive wear was observed on the inner cutter when compared to the degree of wear based on continuous actuation of the probe visual standard photos.The inner cutter is bent.Damage was observed on the cutting edge.Gouge marks were observed at the bend area, cutting edge, and several other locations along the inner cutter.The complaint evaluation confirmed that the probe had a broken tip at the port.The manufacturing site reviewed the surgical video, which confirms the tip fell into the eye and was retrieved.The manufacturing site is unable to determine the total cutter actuation time from review of the video.The exact root cause for the broken tip cannot be determined from this evaluation.The most likely contributing factor to the broken tip at the port is 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.How and when the inner cutter of the probe became damaged cannot be determined from this evaluation.A damaged inner cutter can impede the movement of the cutter shaft, causing the probe to not be able to perform the cut.An internal investigation has been initiated to further evaluate the cause of probe tip breakage at the port.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Complaints will continue to be reviewed and closely 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 VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer (Section G): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7877140
• MDR Text Key: 120407253
• Report Number: 2028159-2018-01942
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K101285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TABLETOP-JAPAN
• Device Catalogue Number: 8065751817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2018
• Initial Date FDA Received: 09/14/2018
• Supplement Dates Manufacturer Received: 12/06/2018
• Supplement Dates FDA Received: 01/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1