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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 3MM KERRISON RONGEURS

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CAREFUSION, INC T-COAT MICRO HDL KERR RONG THIN 8IN 3MM KERRISON RONGEURS Back to Search Results
Catalog Number NL4252-83T
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/26/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6). On 08 apr 2019 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
Via voicemail: customer stated that they had an issue with one 3 mm kerrison in their possession. No additional information was provided by the rep at this time. On 15 apr 2019 additional information: was the product received in this condition? no. If not, what was the product being used for when it was observed that it had an issue? product was being used on a patient during an ortho-spine procedure. Please confirm whether or not there was any patient impact. No harm to the patient has been reported. Do you have the lot #? unknown. What exactly is wrong with the product? instrument broke. The tip of the 3 mm kerrison broke off. The kerrison will be returned but the tip piece that broke off was lost when it was cleaned after the incident. Do you have the product number? yes, nl 4252-83t. No further information available. On 18 apr 2019 additional information: did any part the instrument fall into the patient's body, and if so how was it retrieved? yes, the tip of the instrument fell into the body and was retrieved with surgical pickups under direct visualization. Was there a medical procedure performed to verify if the instrument was in the patient's body, such as an x-ray? no, as the instrument tip was directly visualized and removed immediately at time of incident. What was the patient's outcome? procedure was completed as planned and patient was discharged same day. Was the procedure completed as planned? yes.
 
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Brand NameT-COAT MICRO HDL KERR RONG THIN 8IN 3MM
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
MDR Report Key8540539
MDR Text Key151943695
Report Number1423507-2019-00007
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 company representative,consum
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 05/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNL4252-83T
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/26/2019
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: 04/23/2019 Patient Sequence Number: 1
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