MAUDE Adverse Event Report: W&H IMPEX DU1000 MOTOR WITH CABLE, 1.8M/5.9FT; HANDPIECE

Catalog Number DU1KMC

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: DU1000 MOTOR WITH CABLE, 1.8M/5.9FT
• Type of Device: HANDPIECE
• Manufacturer (Section D): W&H IMPEX; 14300 henn street; dearborn MI 48126
• MDR Report Key: 7244670
• MDR Text Key: 99125432
• Report Number: 0001038806-2018-00089
• 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: 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: DU1KMC
• Device Lot Number: 02514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2018
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/17/2018
• Event Location: Other
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention