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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC LOVE-GRUENWALD PITUITARY FORCEPS 2X10MM RONGEUR, MANUAL

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CAREFUSION, INC LOVE-GRUENWALD PITUITARY FORCEPS 2X10MM RONGEUR, MANUAL Back to Search Results
Catalog Number NL6146
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/18/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). On 19feb2020 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. Customer submitted emdr and provided uf/importer report # 2301650000-2020-8001.
 
Event Description
Via email: the jaws of the narrow pituitary, out of the neuro ronguer set 002, broke while operating inside the disc space. Per the scrub tech, the instrument was not damaged or bent prior to doctor using it. Surgery was prolonged while trying to retrieve the broken piece of the instrument. The broken piece was successfully removed from the patient. What was the original intended procedure: microdiskectomy percutaneous, minimally invasive laminectomy. Additional procedure information: minimally invasive left l5-s1 hemi laminectomy with foraminotomy and microdiskectomy w/fluoro and nuvasive neuro monitoring (b)(6) 2020. The patient is a (b)(6) year old white male. 25feb2020 additional information: was there a medical procedure performed to verify if the instrument was in the patient¿s body, such as an x-ray? no xray was necessary. The broken piece was successfully removed from the patient. What was the patient¿s outcome? no harm. No further information available.
 
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Brand NameLOVE-GRUENWALD PITUITARY FORCEPS 2X10MM
Type of DeviceRONGEUR, MANUAL
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 Key9764341
MDR Text Key184642407
Report Number1423507-2020-00009
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 03/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNL6146
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 Received02/18/2020
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: 02/27/2020 Patient Sequence Number: 1
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