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

Model Number	DGH 6000
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Thus far, little information has been provided by the user related to the event.Requests for additional information have yet to be fulfilled.From the information provided, it appears that the probe may have been applied off-axis to the eye (incorrect manual applanation by the user), resulting in an incorrect axial length measurement.However it is not possible to conclusively determine this without additional information by the user.The distributor ((b)(4)) has arranged to follow up with user (dr.(b)(6)) in february (16th-19th).Device production history for unit 2016-0387 has been reviewed.No production/quality control issues were identified.Device labeling (user instructions) is under review for efficacy and clarity.
Event or Problem Description
A distributor ((b)(4)) stated that a user (dr.(b)(6)) alleged his device was not giving a proper reading when performing measurements.When contacted for additional information, dr.(b)(6) stated that using measurements taken with the device (for iol calculations) yielded a refractive error of -3.00, -3.50 and -2.50 diopters, which was greater than the desired result.Dates of event unknown.The doctor stated that rayner intraocular lenses were used (power and model unknown).Patient information was not given, however from the description provided it appears that patients experienced this level of refractive error following surgery.Necessity of additional medical/surgical intervention unknown.

• Brand Name: SCANMATE A
• Common Device Name: OPHTHALMIC A-SCAN
• Manufacturer (Section D): DGH TECHNOLOGY, INC.; 110 summit drive; suite b; exton PA 19341
• MDR Report Key: 6281074
• Report Number: 2522950-2017-00001
• Device Sequence Number: 1075003
• Product Code: IYO
• UDI-Device Identifier: 00857377006094
• UDI-Public: (01)00857377006094
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 12/26/2016

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2016
• Initial Report FDA Received Date: 01/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: APPASAMY KERATOMETER
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Weight: 91