MAUDE Adverse Event Report: W&H IMPEX WS-75, HANDPIECE - DU900

Catalog Number DU9WS75

Device Problem Mechanical Problem (1384)

Patient Problem No Information (3190)

Event Date 01/17/2018

Event Type  Injury  

Event Description

The doctor reported that the handpiece (du9ws75) malfunctioned and that he was unable to complete the procedure. The patient will return at a later date.

• Brand Name: WS-75, HANDPIECE - DU900
• Type of Device: HANDPIECE
• Manufacturer (Section D): W&H IMPEX; 14300 henn street; dearborn MI 48126
• MDR Report Key: 7244198
• MDR Text Key: 99128119
• Report Number: 0001038806-2018-00088
• Device Sequence Number: 1
• Product Code: EKX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Catalogue Number: DU9WS75
• Device Lot Number: 11601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Distributor Facility Aware Date: 01/17/2018
• Event Location: Other
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 02/06/2018 Patient Sequence Number: 1