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

Model Number TABLETOP

Device Problems Air Leak (1008); Failure to Cut (2587)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/11/2018

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 nurse reported that the probe cutting was poor and bubbles appeared during a procedure.The aspiration function is unknown.The product was replaced and procedure completed with no patient harm.No additional information is expected.

Manufacturer Narrative

Additional information provided.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 is one additional complaint associated with the lot for the reported issue.A sample was not returned and the device history record review of the lot number provided indicated the product was processed and released according to the product¿s acceptable criteria, therefore, the root cause for the customer complaint issue cannot be determined.The exact root cause for this complaint is unknown as no sample was returned; therefore, specific action with regards to this complaint cannot be taken.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Any non-conformances found are removed from the lot and scrapped.Complaints are reviewed and 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).

Manufacturer Narrative

Additional information provided.One opened probe was received and visually inspected and was found non-conforming with possible surgical debris on the needle near the stiffener, foreign matter at the port face, and the needle bent above the stiffener.The sample was then functionally tested for aspiration, actuation, and cut.The sample was found conforming for aspiration with no bubbles seen coming from the port and was found non-conforming for actuation and cut.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 severely bent.Gouge marks were observed at the bend area, cutting edge, and a couple of other areas along the inner cutter.After disassembly (bent needle and shell removed), the probe was able to actuate.The complaint evaluation confirms the probe had a cut issue as reported, however, the complaint evaluation does not confirm the presence of bubbles.The root cause for the actuation and cut non-conformances and the possible surgical debris on the needle, foreign matter in the port, and bent inner cutter is due to 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 has 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.The exact root cause of the bent needle and inner cutter cannot be determined from this evaluation.The most likely root cause is handling at any point after the probe was shipped from the manufacturing site including use during surgery.No action has been taken as it appears that the observed non-conformances were due to excessive use of the probe by the user and the complaint evaluation did not confirm the presence of bubbles.Probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Any non-conformances found are removed from the lot and scrapped.Complaints are reviewed and 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
• MDR Report Key: 7477213
• MDR Text Key: 107213612
• Report Number: 2028159-2018-00896
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K101285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/03/2018

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
• Device Catalogue Number: 8065751150
• Other Device ID Number: 380657511501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2018
• Initial Date Manufacturer Received: 04/11/2018
• Initial Date FDA Received: 05/01/2018
• Supplement Dates Manufacturer Received: 05/03/2018; 11/16/2018
• Supplement Dates FDA Received: 05/29/2018; 12/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION SURGICAL PROCEDURE PAK
• Patient Outcome(s): Other