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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CNPJ: 53.168.142/0001-29 EASYDRILL PERFORATOR; DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOU

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CNPJ: 53.168.142/0001-29 EASYDRILL PERFORATOR; DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOU Back to Search Results
Model Number DM0011FAA
Device Problem Device Remains Activated (1525)
Patient Problem Perforation (2001)
Event Date 10/05/2022
Event Type  Injury  
Manufacturer Narrative
No evaluation was performed, as the device was not returned.If the device is returned in the future, product analysis may be performed.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during a craniotomy/tumor resection case, the surgeon was drilling 3 holes using the perforator.The first 2 holes went fine, however while drilling the third hole it was reported that instrument seemed to plunge forward and ended up hitting the dura of the patient.No significant patient harm was reported.On follow up it was reported that there was no additional action taken to prevent impact or injury and there was no delay in procedure as a result of this event.
 
Manufacturer Narrative
Correction: updated d9, h3, h6 (imdrf c and d codes), h7 and h10 as the device returned for evaluation.Summary correction (h10): no conclusion can be drawn.Device was returned and the evaluation anticipated but not yet begun.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
EASYDRILL PERFORATOR
Type of Device
DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOU
Manufacturer (Section D)
CNPJ: 53.168.142/0001-29
av. marginal ao corrego da ser
sao paulo
sp,br 09980 -39
BR  09980-39
Manufacturer (Section G)
CNPJ: 53.168.142/0001-29
av. marginal ao corrego da ser
sao paulo
sp,br 09980 -39
BR   09980-39
Manufacturer Contact
natalia matos
cnpj: 53.168.142/0001-29
av. marginal ao corrego da ser
sao paulo,sp 09980--39
BR   09980-39
140575722
MDR Report Key15723077
MDR Text Key303035112
Report Number1625507-2022-00246
Device Sequence Number1
Product Code HBF
UDI-Device Identifier07898959543173
UDI-Public07898959543173
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141455
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/08/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberDM0011FAA
Device Catalogue NumberDM0011FAA
Device Lot Number1083/20
Was Device Available for Evaluation? Device Returned to Manufacturer
Initial Date Manufacturer Received 10/06/2022
Initial Date FDA Received11/03/2022
Supplement Dates Manufacturer Received01/10/2023
Supplement Dates FDA Received02/08/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/06/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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