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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC T-COAT MICRO HDL KERR RONG THIN 8IN 2MM KERRISON RONGEURS

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CAREFUSION, INC T-COAT MICRO HDL KERR RONG THIN 8IN 2MM KERRISON RONGEURS Back to Search Results
Catalog Number NL4258-82T
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/23/2020
Event Type  malfunction  
Manufacturer Narrative
Pr # (b)(4). (b)(6) 2020 writer sent the customer an email acknowledging receipt of the complaint, providing the complaint tracking number and requested follow up information including as to if there was any patient impact related to this event. Writer provided contact information. Device not yet evaluated, if the device is evaluated a follow up will be sent.
 
Event Description
Per email: event description per attached email states: a tiny piece that broke off during a procedure. 30sep2020 additional information: what was the procedure that was being performed? the procedure being performed was a laminectomy. Did any part the instrument fall into the patient¿s body, and if so how was it retrieved? the tip of the roguer broke off and fell into the incision area and went in between the lamina and the dura. Was there a medical procedure performed to verify if the instrument was in the patient¿s body, such as an x-ray? there was x-ray being done throughout the case. What was the patient¿s outcome? the patient¿s outcome was fine. Was the procedure completed as planned? yes, the procedure was completed as planned. Can you please send all parts of the instrument for evaluation? yes, we can send the parts. Do you have the lot number? na. No further information available.
 
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Brand NameT-COAT MICRO HDL KERR RONG THIN 8IN 2MM
Type of DeviceKERRISON RONGEURS
Manufacturer (Section D)
CAREFUSION, INC
75 north fairway drive
vernon hills IL 60061
Manufacturer (Section G)
CAREFUSION, INC
75 north fairway drive
vernon hills IL 60061
Manufacturer Contact
anna wehrheim
75 north fairway drive
vernon hills, IL 60061
8015652341
MDR Report Key10609265
MDR Text Key221547261
Report Number1423507-2020-00043
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PREAMENDMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNL4258-82T
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/24/2020
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

Patient Treatment Data
Date Received: 09/30/2020 Patient Sequence Number: 1
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