MAUDE Adverse Event Report: TOPCON MEDICAL LASER SYSTEMS INC. PASCAL SYNTHESIS 532/577

Model Number SA-06280

Device Problems Device Alarm System (1012); Energy Output Problem (1431); Use of Device Problem (1670)

Patient Problem Retinal Injury (2048)

Event Date 11/28/2016

Event Type  Injury  

Manufacturer Narrative

Upon analysis of the system log by tmls r and d - it was confirmed that the log file, calibration data, alarm setting and treatment database are all functioning according to specifications.Further investigation needed.Place of event: (b)(6) hospital.

Event Description

Field service engineer received a call from a customer regarding pascal synthesis.S.No.(b)(4).As reported by the field service engineer, the caller stated as follows: "a patient while receiving treatment started to shout because he overcooked the patient's retina.He immediately lowered the power from 200mw to 150mw and then to 100mw and time exposure from 20ms to 15ms." as reported - the laser was used with the following configuration to treat a patient: 200ms patterns; power 200mw; exposure 20ms; spot diameter 200um; spot spacing 1.50; epm off; 37 spots.The user stated that he didn't get any error messages regarding the power being over expected although he mentioned that in the information window he got 1.332 written in yellow next to default.

Event Description

Additional information to previously submitted mdr on 12/02/2016.The system was investigated and was found to be working in accordance with specifications.The event on (b)(6) 2016 is suspected to have been caused because of error on the user's part.The treatment parameters chosen by the physician are expected to cause pain.The patient is not experiencing any adverse effects as a result of this incident, as reported by topcon ((b)(4)) representative - after visiting the site and investigating the issue.The yellow default message observed as because the clinician was not holding down the footswitch for long enough, leading to an incomplete pattern delivery.This caused the odd shaped pattern deliveries observed on the day, and the zig zag line pattern when the patient moved.The clinician was trained on 12/09/2016.An additional training is scheduled for 01/18/2016.

• Brand Name: PASCAL SYNTHESIS 532/577
• Type of Device: PASCAL SYNTHESIS
• Manufacturer (Section D): TOPCON MEDICAL LASER SYSTEMS INC.; 606 enterprise ct; livermore CA 94550
• Manufacturer (Section G): TOPCON MEDICAL LASER SYSTEMS, INC.; 606 enterprise ct.; livermore CA 94550
• Manufacturer Contact: sweta srivastava ; 606 enterprise ct.; livermore, CA 94550 ; 9252457721
• MDR Report Key: 6247201
• MDR Text Key: 64675647
• Report Number: 3008599994-2016-00003
• Device Sequence Number: 1
• Product Code: HQF
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K123542
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Service Personnel
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SA-06280
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• 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): Other; Required Intervention