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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDLESS DRIVER 4 HANDPIECE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

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CORDLESS DRIVER 4 HANDPIECE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Model Number 4405000000
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/30/2021
Event Type  malfunction  
Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program. Reported events: 3 events were reported for this quarter. Product return status: 3 device investigation types have not yet been determined. Additional information: 3 devices were not labeled for single-use. 3 devices were not reprocessed or reused.
 
Event Description
This report summarizes 3 malfunction events in which the device was reportedly leaking. 3 events had no patient involvement; no patient impact.
 
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Brand NameCORDLESS DRIVER 4 HANDPIECE
Type of DeviceINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
MDR Report Key12677865
MDR Text Key277856864
Report Number3015967359-2021-02198
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Number of Events Reported6
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 10/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number4405000000
Device Catalogue Number4405000000
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/30/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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