MAUDE Adverse Event Report: W&H POWER CONSOLE FOR DU900; CONSOLE SURGICAL UNIT

Catalog Number DU9CON

Device Problem Product Quality Problem (1506)

Patient Problem No Information (3190)

Event Date 02/23/2017

Event Type  Injury  

Event Description

It was reported that the drill unit gives the error code 4 and does not work.Patient was closed up and sent home.Patient will be returned to the office when the unit is repaired.

• Brand Name: POWER CONSOLE FOR DU900
• Type of Device: CONSOLE SURGICAL UNIT
• Manufacturer (Section D): W&H; ignaz-glaser-strasse 53; postfach 1; bürmoos 5111 ; AU 5111
• MDR Report Key: 6422103
• MDR Text Key: 70515176
• Report Number: 0001038806-2017-00098
• Device Sequence Number: 1
• Product Code: EBW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 02/23/2017,03/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Catalogue Number: DU9CON
• Device Lot Number: SN 04377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/23/2017
• Event Location: Other
• Date Report to Manufacturer: 02/23/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention