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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO SAGITTAL SAW; UNIT, OPERATIVE DENTAL
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MICRO SAGITTAL SAW; UNIT, OPERATIVE DENTAL Back to Search Results
Catalog Number 5100034000
Device Problem Overheating of Device (1437)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/30/2020
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.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 reportedly overheated.1 event had no patient involvement; no patient impact.
 
Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale corrected data: b5, h10 1 previously reported event is included in this follow-up record.Product return status 1 device was not available for evaluation.H3 other text : device not available.
 
Event Description
This report summarizes 1 malfunction event in which the device reportedly overheated.- 1 event had no patient involvement; no patient impact.
 
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Brand Name
MICRO SAGITTAL SAW
Type of Device
UNIT, OPERATIVE DENTAL
MDR Report Key10329670
MDR Text Key200629925
Report Number0001811755-2020-01840
Device Sequence Number1
Product Code EIA
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 07/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number5100034000
Was Device Available for Evaluation? No
Date Manufacturer Received06/30/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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