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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYSTEM 7 DUAL TRIGGER ROTARY HANDPIECE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

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SYSTEM 7 DUAL TRIGGER ROTARY HANDPIECE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Model Number 7205000000
Device Problem Unintended Power Up (1162)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/30/2021
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: 1 event was reported for this quarter. Product return status: 1 device investigation type has not yet been determined. Additional information: 1 device was not labeled for single-use. 1 device was not reprocessed or reused.
 
Event Description
This report summarizes 1 malfunction event in which the device ran without user activation. 1 event had no patient involvement; no patient impact.
 
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Brand NameSYSTEM 7 DUAL TRIGGER ROTARY HANDPIECE
Type of DeviceINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
MDR Report Key12203664
MDR Text Key262701479
Report Number3015967359-2021-01556
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 10/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7205000000
Device Catalogue Number7205000000
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/30/2021
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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