MAUDE Adverse Event Report: TOPCON HEALTHCARE SOLUTIONS, INC SYNERGY ODM; OPHTHALMIC IMAGE MANAGEMENT SYSTEM

Model Number 4.06.004.14719

Device Problem Data Problem (3196)

Patient Problems Unspecified Eye / Vision Problem (4471); Insufficient Information (4580)

Event Date 08/17/2022

Event Type  Injury  

Manufacturer Narrative

Synergy odm is a discontinued samd with only 11 instances remaining in the united states.During the initial investigation, topcon support and engineering remoted directly into the customer's environment to attempt reproduction of the issue.The exam in question was printed correctly, and the reported issue could not be reproduced.It was noted that patient "mr" did not have any images stored in synergy and no link between the two patients could be found via a database search.Topcon has made multiple requests to the customer for additional information about the workflow used by the customer so that another attempt can be made to reproduce the issue and identify the cause, but no feedback has been provided to topcon.The customer was also asked why a patient agreed to have a surgery performed if, as found by topcon engineering, there are no images or exam records under the patient's id in synergy, but no response has been provided at this time.

Event Description

The end user reported that synergy software printed the incorrect patient name (patient mr) in the header of the exam for another patient (la) resulting in two names present on a single page.The end user reported that this resulted in a mis-diagnosis and improper surgery for the patient (mr).The type of surgery performed and information regarding the patient outcome including whether there will be any permanent consequences or whether additional surgery was necessary to correct the patient remains unknown in spite of multiple requests to disclose this information.Topcon healthcare solutions support was unable to reproduce the issue when remoted into the customer's environment.

Manufacturer Narrative

Consultation between a technician and the physician to determine whether any particular workflow contributed to the error proved to be inconclusive.The remaining hypothesis is that an error occurred in the user's browser cache that resulted in this error, but since the cache is not maintained this cannot be verified.The customer impacted by this error will be transitioned to an alternative software solution to prevent any reoccurrence that may be caused by the user environment or user workflow.Corrected data: b1: corrected to "adverse event".B2: corrected to "required intervention to prevent permanent impairment/damage".B5: added new information.H1: corrected to "serious injury".H6: corrected clinical code to 4471, "unspecified eye/vision problem"; corrected impact code to 4629, "device revision or replacement".H10: added new information to narrative.

Event Description

The patient underwent a corrective surgery to have their bilateral lenses replaced with those of the correct prescription.This corrective surgery occurred the day after the initial incident, and no post-operation issues have been reported since then.

• Brand Name: SYNERGY ODM
• Type of Device: OPHTHALMIC IMAGE MANAGEMENT SYSTEM
• Manufacturer (Section D): TOPCON HEALTHCARE SOLUTIONS, INC; 111 bauer drive; oakland NJ 07436
• Manufacturer Contact: ian boland ; 111 bauer drive; oakland, NJ 07436 ; 5512704341
• MDR Report Key: 15869003
• MDR Text Key: 307673067
• Report Number: 3013986459-2022-00001
• Device Sequence Number: 1
• Product Code: NFJ
• UDI-Device Identifier: 00852683007018
• UDI-Public: 00852683007018
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K151952
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4.06.004.14719
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/30/2022
• Initial Date FDA Received: 11/28/2022
• Supplement Dates Manufacturer Received: 10/30/2022
• Supplement Dates FDA Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 66 KG