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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 1MM KERRISON RONGEURS

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CAREFUSION, INC T-COAT MICRO HDL KERR RONG THIN 8IN 1MM KERRISON RONGEURS Back to Search Results
Catalog Number NL4252-81T
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/17/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). On (b)(6) 2018 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 phone conversation: jaw has broken. Additional information received via email on (b)(6) 2018: the date of use was actually 2 different dates. One was on tuesday (b)(6) 2018, and the other on (b)(6) 2018. The kerrisons did break while we were using them in patient¿s necks. There was luckily no harm to the patient or the doctor. Both of the kerrisons that we recently ordered have broken. Lot numbers- c17xme and l17xme. (b)(6) 2018 additional information: patient information: (age, gender, weight) one male, (b)(6), bmi (b)(6). One female, (b)(6), bmi (b)(6). Was there any patient medical intervention? no. What was the patient¿s medical status after the event? stable. Did any part of the device break/fall into the patient¿s body field? yes, the broken piece of the jaw fell into the neck. If yes how was the object retrieved? with the suction and forceps. Did the patient require an additional medical procedure such as an x-ray? no. How was the event resolved, was the device removed from use and replaced with another? kerrisons were removed from our sets, and now we have two sets down that are incomplete. What type of procedure was being performed? they were both acdf's. Was the procedure completed as planned? yes. Has your facility reported the event to the fda? no. No further information available.
 
Manufacturer Narrative
The sample was provided and an evaluation was performed. The instrument was manufactured in december of 2017. The root cause is that the punches have been overstressed. Notches in the jaws indicate that the kerrison was used to cut wire. The hardness is 47. 0 hrc (inside the tolerance 43-48 hrc). There have been no issues identified with the material or manufacturing process. The product has been manufactured and tested according to the specifications. A review of the device history records (dhr) did not identify and issues that would have contributed to the reported issue.
 
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Brand NameT-COAT MICRO HDL KERR RONG THIN 8IN 1MM
Type of DeviceKERRISON RONGEURS
Manufacturer (Section D)
CAREFUSION, INC
75 n. fairview drive
vernon hills IL 60061
MDR Report Key7529811
MDR Text Key109232186
Report Number1423507-2018-00008
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
PMA/PMN Number
PREAMENDMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 06/05/2018
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 NumberNL4252-81T
Device Lot NumberL17XME
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/01/2018
Is This a Reprocessed and Reused Single-Use Device? No

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