MAUDE Adverse Event Report: DGH TECHNOLOGY, INC. SCANMATE A; ULTRASONIC A-SCAN

Model Number DGH 6000

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

As of 12/20/2016, the device has been returned to the distributor ((b)(4)).(b)(4) is to coordinate returning the device to dgh.

Event Description

A user (dr.(b)(6)) alleged experiencing measurement errors when using a dgh 6000 a-scan device.The doctor stated that when performing contact axial length measurements of the eye, (in approximately 2 of every 10 cases) he would have difficulty obtaining measurements.He said in these instances the device would enter estimate mode and measurements taken while in estimate mode differed from axial length measurements achieved with his previous a-scan device.This difference in measurement would result in a refractive calculation error of 2-3 diopters.The doctor claimed that instances of difficulty were typically experienced when attempting to measure eyes with a mature cataracts or posterior sub capsular cataract (psc).He stated that in other cases (when not measuring mature cataracts or posterior sub capsular cataract), the readings are satisfactory and accurate.Measurement information for one patient ((b)(6)) was provided, whose measurements differed by 0.75 mm when compared to the previous device.The doctor has stated that no injuries have occured as a result of the measurement difference.In cases where measurements obtained with the dgh 6000 differed from his previous device, measurements achieved with the previous device were used for refractive calculations.

• Brand Name: SCANMATE A
• Type of Device: ULTRASONIC A-SCAN
• Manufacturer (Section D): DGH TECHNOLOGY, INC.; 110 summit drive; suite b; exton PA 19341
• Manufacturer (Section G): DGH TECHNOLOGY, INC.; 110 summit drive; suite b; exton PA 19341
• Manufacturer Contact: andrew farrugia ; 110 summit drive; suite b; exton, PA 19341 ; 6105949100
• MDR Report Key: 6190143
• MDR Text Key: 63210050
• Report Number: 2522950-2016-00001
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00857377006094
• UDI-Public: (01)00857377006094
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K093371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 11/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: DGH 6000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2015
• 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 Age: 60 YR