MAUDE Adverse Event Report: CLARITY MEDICAL SYSTEMS, INC. RETCAM SHUTTLE; OPHTHALMIC CAMERA

Model Number RETCAM SHUTTLE

Device Problems Corroded (1131); Use of Device Problem (1670); Device Disinfection Or Sterilization Issue (2909)

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

Event Date 09/17/2015

Event Type  malfunction  

Manufacturer Narrative

The customer, dignity health/(b)(6), purchased a retcam shuttle system (b)(4) and an accessory rop lens (model d1300 serial (b)(4)) on (b)(6) 2014.The unit was installed on (b)(4) 2014.User training was performed by clarity personnel on (b)(4) 2014.No reported issues with regard to the retcam shuttle (b)(4) device, only the accessory rop lens was returned for examination.The visual examination of the returned rop lens revealed that there was no visual corrosion on the metal as alleged.Note: the metal area does not come in contact with the patient.Additionally, the returned lens passed all product performance tests.The lens design has been in use since 1999 and to date, this is the only report of alleged lens corrosion caused by the cleaning solution.Clarity medical has provided hospital personnel with alternate disinfection solutions that can be used with the lens.Clarity considers the matter closed.Mdr response timeline nov 10, 2015 clarity completed mdr response forms.Nov 11, 2015 start process to submit emdr's.Nov 11, 2015 install esubmitter application and request a new (b)(4) test account registration for submitting test emdr electronically.Nov 11, 2015 (b)(4) letters of non-repudiation agreement to fda.Nov 12, 2015 receive confirmation that (b)(4) test account has been created.Nov 13, 2015 obtain and created a personal digital certificate required for submitting emdr's through (b)(4).Nov 17, 2015 clarity experienced problems configuring (b)(4) test account.An email was sent to (b)(4) for additional information and help in resolving the issue.Nov 17, 2015 contacted fda mdr policy branch to report we were experiencing difficulties configuring our emdr account and asked how to handle the mdr reporting deadline.Clarity was informed by fda personnel to detail why our mdr response was late.Nov 17, 2015 send small text submission, test successful.Nov 24, 2015 clarity submitted a test emdr through (b)(4) that failed due to report id.Dec 1, 2015 receive email from (b)(4) notifying me to contact (b)(4) to resolve the error message, report id failed.Dec 2, 2015 clarity received notification from (b)(4) to re-submit emdr against new schema.Dec 3, 2015 clarity re-submitted test emdr, which continued to receive fail messages.Dec 3, 2015 clarity received additional instructions from (b)(4) on how to resolve error message.Dec 10, 2015 clarity was partially successful in submitting emdr, files received, however failed due to exceeding character limit of one of the text boxes.Dec 14, 2015 clarity's vp operations and qa/ra received an email from (b)(4) notifying clarity that a device registration monitor in our area asked for a change to our firm's (b)(4).No additional information was given, but (b)(4) report number was one of the recurring error messages, we received during our test submission.Dec 15, 2015 clarity submitted test emdr and was finally successful in submitting a test emdr.Dec 15, 2015 sent email to (b)(4) requesting my account be migrated to production.Dec 17, 2015 clarity received the following email from (b)(4) (wrote) it can take up to one full week for your fda center to respond whether or not your guidance compliant submission has passed validation.Once they have responded that your submission has passed we will then approve your production account.Jan 14, 2016 clarity sent email to (b)(4) requesting a status update to our successful test submission on dec 14, 2015.Jan 14, 2016 clarity received an email from (b)(4), sent the following message to (b)(4) "would you mind telling me the status of the following guidance compliance submission?" (b)(4).Jan 14, 2016 clarity received an email from (b)(4) (cesub help desk wrote) "thank you for your email.We have assigned (b)(4) to this issue.Our technical team is currently reviewing the request.We will get back to you shortly if any more information is needed." jan 14, 2016 clarity received the following email from (b)(4) (cesub help desk wrote) the following email to (b)(4): "below test submission passed validation process and can be approved for the production account." jan 14, 2016 clarity received the following email from (b)(4) (wrote) "your (b)(4) test account "clarity medical systems, inc." has been migrated into the production system.You are now ready to send submissions to the fda using the following information.Log into the production system at (b)(4) using the same user id, password, and certificate as your test account." jan 15, 2016 clarity submits emdr through (b)(4).Jan 20, 2016 clarity received an email from (b)(4) that our report was incorrectly marked as "follow-up" and should be marked as "initial report".Jan 21, 2016 clarity received an email from (b)(4) "we are going to remove the supplements you sent below from emdr.Once they have been removed, we will ask you to resubmit corrected versions with marked as initial.Please do not submit the initial reports until we notify you." jan 21, 2016 clarity received an email from (b)(4) "the erroneous supplemental reports have been removed from emdr.Please use esubmitter to correct both reports so they are marked initial, then repackage and resubmit.If the 30-day reporting timeframe has already passed, you may also make a note explaining the situation." jan 22, 2016 clarity resubmits emdr through (b)(4).Jan 25, 2016 receive acknowledgement from (b)(4) that manufacturer number is not valid - failed and submission failed jan 26, 2016 clarity resubmits emdr through (b)(4) jan 26, 2016 receive acknowledgement from (b)(4) that manufacturer number is not valid - failed and submission failed.Jan 26, 2016 clarity sends email to (b)(4) along with error message requesting if our manufacture report number is still valid.Why does our submission continues to fail when the only change from the first submission to our second submission on changing one simple check box? jan 27, 2016 clarity received an email from (b)(4)) your esg/emdr account is still active, this issue is related to the registration numbers that are on file in fda's furls database.When i look at your firm's entry (b)(4).I see that you have both a cfn (b)(4) and an fei (b)(4) but i can only find your firm when i search by cfn.Since you sent the reports last year, i am wondering if something changed in the (b)(4) database when we entered into 2016.Emdr did accept reports with your fei in 2015, but for some reason it won't in 2016.There are two possible resolution paths i see: file your reports using your cfn instead of your fei, troubleshoot your fei not being valid with the furls folks through their helpdesk at (b)(4).Jan 27, 2016 clarity resubmits emdr through (b)(4) using our cfn number.Clarity will work with furls to see what change with our fei number from 2015 to 2016.

Event Description

Dignity health reported through medwatch, concerns regarding the disinfection of the retcam lens; possible lens corrosion (on the metal) caused by using bleach solution.Moreover, alternative disinfection solutions (listed in the user manual) are not available.

• Brand Name: RETCAM SHUTTLE
• Type of Device: OPHTHALMIC CAMERA
• Manufacturer (Section D): CLARITY MEDICAL SYSTEMS, INC.; 5775 west las positas blvd; suite 200; pleasanton CA 94588 4084
• Manufacturer (Section G): CLARITY MEDICAL SYSTEMS, INC.; 5775 west las positas blvd; suite 200; pleasanton CA 94588 4084
• Manufacturer Contact: eric steuben ; 5775 west las positas blvd; suite 200; pleasanton, CA 94588-4084 ; 9254637984
• MDR Report Key: 5397781
• MDR Text Key: 38234143
• Report Number: 2952489-2016-00001
• Device Sequence Number: 1
• Product Code: HKI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 10/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RETCAM SHUTTLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/27/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1