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

Model Number TABLETOP

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 11/21/2019

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 surgeon reported the system displayed an error code that the diathermy output was out of range.The cautery was set to 12% fixed, however pressing down on footpedal resulted in system behaving like it was 100%.The probe and cable were exchanged but the system behavior did not change.The retina was being scalded and bits of the retina were burning off.

Manufacturer Narrative

Additional information is provided in d.10., g.1., g.2., h.3., h.6.And h.10.The customer called to report a system message (sm) [diathermy failure: dc2dc output was out of range.Diathermy functions will be disabled].The surgeon noted the cautery was set to 12% fixed.However, when pressing down on the footswitch, it resulted in the system behaving as if it was at 100% with the retina getting scalded and bits of retina burning off.The surgeon noted even when the value was set to 2% it was fizzing.Both the probe and the cable were swapped out but the system behavior did not change.Additional information received from the surgeon noted no adverse effects to the patient.The surgeon tested the diathermy in a non-critical area of vitreous when he noted the high output.To ensure safe operation of the diathermy function, use only alcon cables and accessories.Diathermy performance can be guaranteed only when using manufacturing surgical components or mfg-endorsed components.Cables should always be positioned in such a way that contact with the patient is prevented.The operator¿s manual includes warnings: do not use the diathermy function on patients with pacemakers or implanted defibrillatory devices.If electrosurgery is used on patients with implanted cardiac pacemakers, defibrillatory devices, or pacemaker electrodes, be aware that irreparable damage to the pacemaker or defibrillatory device and its function may occur and lead to ventricular fibrillation.Please check with the pacemaker or defibrillatory device manufacturers for their recommendations.Failure of the hf surgical equipment (diathermy circuitry) could result in an unintended increase of output power.In this event, the following advisory is displayed: ¿handpiece power is too high.Release footswitch button/treadle and try again.¿ listed below are general precautions to be followed when using the diathermy function: ¿ to ensure safe operation of the diathermy function, only approved cables and accessories must be used (see your representative).Diathermy performance can be guaranteed only when using alcon components or mfg-endorsed components.¿ to reduce the risk of accidental burns, caution should always be taken when operating high-frequency surgical equipment.¿ interference produced by the operation of high-frequency surgical equipment may adversely influence the operation of other electronic equipment.¿ accessories should be checked regularly; electrode cables should particularly be checked for possible damage to the insulation.¿ the lowest power level in diathermy step should always be selected for the intended purpose.¿ skin-to-skin contact (for example between the arms and body of the patient) should be avoided, for example by insertion of dry gauze.¿ when hf (high frequency) surgical equipment and physiological monitoring equipment are used simultaneously on the same patient, any monitoring electrodes should be placed as far as possible from the surgical electrodes.Needle monitoring electrodes are not recommended.¿ in all cases, monitoring systems incorporating high frequency current-limiting devices are recommended.¿ the cables to the surgical electrodes should be positioned in such a way that contact with the patient or other leads is avoided.¿ temporarily unused active electrodes should be stored so that they are isolated from the patient.¿ the use of flammable anaesthetics or oxidizing gases such as nitrous oxide (n2o) and oxygen should be avoided if a surgical procedure is carried out in the region of the thorax or the head, unless these agents are sucked away.Non-flammable agents should be used for cleaning and disinfection wherever possible.¿ flammable agents used for cleaning or disinfecting, or as solvents of adhesives, should be allowed to evaporate before the application of hf surgery.Some materials, for example cotton, wool and gauze, when saturated with oxygen may be ignited by sparks produced in normal use of the hf surgical equipment.¿ accessories of the diathermy function should have a rated voltage equal to or greater than the maximum diathermy output voltage.The company service representative examined the system but was unable to replicate the reported system message (sm) [diathermy failure: dc2dc output was out of range.Diathermy functions will be disabled].The company service representative confirmed the sm in the event log.However, sm [diathermy power is too high.Please release the footswitch treadle / button and try again] was replicated, which was related to the reported sm.The us/diathermy module was replaced to resolve the issue.The system was then tested and met all product specifications.The manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.The root cause of the reported event can be attributed to nonconforming us/diathermy module.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 9615871
• MDR Text Key: 176067977
• Report Number: 2028159-2020-00035
• 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,health
• Type of Report: Initial,Followup
• Report Date: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TABLETOP
• Device Catalogue Number: 8065751150
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/21/2019
• Initial Date FDA Received: 01/22/2020
• Supplement Dates Manufacturer Received: 02/17/2020
• Supplement Dates FDA Received: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other