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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC RHOTON SELLA PUNCH 1MM WIDE UPCUT 45DEG KERRISON RONGEURS

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CAREFUSION, INC RHOTON SELLA PUNCH 1MM WIDE UPCUT 45DEG KERRISON RONGEURS Back to Search Results
Catalog Number NL3785-164
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/01/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4) on 10may2018 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
Medwatch report states: #1 kerrison instrument used during posterior cervical instrumentation. Tip of kerrison noted to have broken off during procedure. Radiographic confirmation obtained that tip of instrument was not retained in patient. Suction filter was radiographed and tip found to be seated in filter of the suction machine. Cpd (central processing department) manager notified. Broken instrument isolated w/suction filter and given to central processing department who dismantled suction filter and sifted piece out. What was the original intended procedure? decompression and fusion posterior cervical spine one lever- c2-c7 fusion posterior cervical spine three or more levels-laminectomy cervical spine with decompression and instrumentation two levels. Patient was not harmed in this incident. On 11may2018 additional information: is it normal procedure to take an x-ray of the patient or was this only done to verify the location of the broken tip of the instrument? it is standard procedure to have c-arm (x-ray) in the room during this procedure. X-ray is used to confirm placement of instrumentation during and immediately prior to patient leaving the or. No further information available.
 
Manufacturer Narrative
Follow up (b)(4) the sample was provided, and an evaluation was performed. The root cause is determined to be from improper maintenance. Hardness is 47. 4 hrc (inside the tolerance 43-48 hrc). Visual inspection of the crack indicates no material defect. The instrument is over 20 years old and appears to have never been sharpened. The blunt blades caused an abrasion which resulted in the weakening of the instrument. There were no issues identified with the material or manufacturing process that would have contributed to the reported issue.
 
Event Description
No further information.
 
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Brand NameRHOTON SELLA PUNCH 1MM WIDE UPCUT 45DEG
Type of DeviceKERRISON RONGEURS
Manufacturer (Section D)
CAREFUSION, INC
75 n. fairview drive
vernon hills IL 60061
Manufacturer (Section G)
CAREFUSION, INC
75 n. fairview drive
vernon hills IL 60061
Manufacturer Contact
anna wehrheim
75 n. fairview drive
vernon hills, IL 60061
MDR Report Key7530173
MDR Text Key109371391
Report Number1423507-2018-00009
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,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNL3785-164
Device Lot NumberXMEA 03
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 Received05/04/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2004
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 05/21/2018 Patient Sequence Number: 1
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