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

Model Number	DGH 6000
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	Visual Impairment (2138)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 12/20/2016 analysis of events and device functionality ongoing.Assessment of measurement records provided to dgh does not necessarily indicate a problem with the device.Without precise post-operative refractive error data, iol calculation reports or patient identification information, conclusive analysis of the event is not possible.A comparative analysis of measurement data is being arranged by the distributor ((b)(4)).
Event or Problem Description
Notification was received from a distributor ((b)(4)) whom dgh had sold a demonstration dgh 6000 a-scan device.This device had been provided by the distributor to a customer for trial use.This device had been in service at the user's facility for several months (start date unknown), with the trial period ending on (b)(6) 2016.It was communicated by the distributor ((b)(4)) that operators of the device had complained that it takes too long to begin measurement and that the readings are unstable.The distributor ((b)(4)) requested that support information be provided by dgh to improve the measurement accuracy of the device.During subsequent communication with the distributor, it was reported to dgh that during the time the dgh 6000 was in trial use, there were ten (10) instances of patients showing a post-operative refractive error of +1.50 through +2.00 diopters, and one (1) instance of a patient showing a post-operative refractive error of +5.00 diopters.During this time, it is estimated that more than two-hundred (200) patients' eyes received surgery with acceptable results (acceptable being less than +1.50 diopter refractive error).It was reported that there were no subsequent surgical corrections performed on any of the eleven (11) patients showing high post-operative refractive errors.The dgh 6000 device is thought to be contributing to the aforementioned events because it is the only equipment changed in previous months.

• Brand Name: SCANMATE A
• Common Device Name: ULTRASONIC A-SCAN
• Manufacturer (Section D): DGH TECHNOLOGY, INC.; 110 summit drive; suite b; exton PA 19341
• MDR Report Key: 6190161
• Report Number: 2522950-2016-00002
• Device Sequence Number: 16249879
• Product Code: IYO
• UDI-Device Identifier: 00857377006094
• UDI-Public: (01)00857377006094
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K093371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 11/29/2016

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?: No
• Operator of Device: Physician
• Device Model Number: DGH 6000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2016
• Initial Report FDA Received Date: 12/20/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR