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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC LEKSELL RONG JAW 3X16MM OVERLGTH 9-3/4IN MANUAL RONGEUR

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CAREFUSION, INC LEKSELL RONG JAW 3X16MM OVERLGTH 9-3/4IN MANUAL RONGEUR Back to Search Results
Catalog Number NL632
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/29/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). On 24oct2017 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. If additional information becomes available a follow up submission will be completed. Not returned.
 
Event Description
Medwatch report: a screw backed out of the rongeur during use. Instrument removed from table. Device usage problem: other. On 14nov2017 additional information: did any part the instrument fall into the patient¿s body, and if so how was it retrieved? the screw fell into the wound and was visible to the surgeon at the time of the occurrence, so he removed it and gave the instrument to the scrub tech to be removed from the surgical field. Was there a medical procedure performed to verify if the instrument was in the patient¿s body, such as an x-ray? no, not need because it was removed at the time of incident.
 
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Brand NameLEKSELL RONG JAW 3X16MM OVERLGTH 9-3/4IN
Type of DeviceMANUAL RONGEUR
Manufacturer (Section D)
CAREFUSION, INC
75 n. fairview drive
vernon hills IL 60061
Manufacturer Contact
anna wehrheim
75 n. fairview drive
vernon hills, IL 60061
MDR Report Key7067443
MDR Text Key93894913
Report Number1423507-2017-00200
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
Type of Report Initial
Report Date 11/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/29/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNL632
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/24/2017
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 11/29/2017 Patient Sequence Number: 1
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