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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC LOVE-GRUENWALD PITUITARY FORCEPS 2X10MM KERRISON RONGEURS

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CAREFUSION, INC LOVE-GRUENWALD PITUITARY FORCEPS 2X10MM KERRISON RONGEURS Back to Search Results
Catalog Number NL6146
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Date 01/09/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4) on (b)(6) 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
It was reported via email: yesterday one of our pituitary¿s had a piece of metal come off during a case. The tech saw it and it wasn¿t left in the patient, but we had to take it out of service. What was the procedure that was being performed? cervical disc replacement. Did any part the instrument fall into the patient¿s body, and if so, how was it retrieved? unknown. Was there a medical procedure performed to verify if the instrument was in the patient¿s body, such as an x-ray? x-ray down, nothing seen on x-ray. What was the patient¿s outcome? stable, normal outcome. Was the procedure completed as planned? yes. Can you please send all parts of the instrument for evaluation? yes, metal piece was found and matched to instrument. Do you have the lot number? j17xsx. Could you please clarify where was the broken piece found? it was found on a sponge by the scrub tech after wiping the instrument after normal use. No further information available.
 
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Brand NameLOVE-GRUENWALD PITUITARY FORCEPS 2X10MM
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 Key8262616
MDR Text Key135508655
Report Number1423507-2019-00001
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,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNL6146
Device Lot NumberJ17XSX
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 Received01/10/2019
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: 01/18/2019 Patient Sequence Number: 1
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