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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC RHOTON BALL DISSECTOR 3MM 90DEG 7-1/2IN RONGEUR, MANUAL

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CAREFUSION, INC RHOTON BALL DISSECTOR 3MM 90DEG 7-1/2IN RONGEUR, MANUAL Back to Search Results
Model Number NL3785-16
Device Problem Detachment Of Device Component (1104)
Patient Problem Foreign Body In Patient (2687)
Event Date 09/23/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). If further information becomes available a follow up medwatch will be submitted.
 
Event Description
Customer stated via email: i would like to know about mri compatibility with the following product: dissector, rhoton, ball, 90deg, 3mm, 7 1/2". Product number nl3785-16. A patient has this product in their body and they are inquiring as to if this product is magnetic. The customer called on the phone, he stated he was the patient that has the device inside of him and was wondering if he could have an mri. This event happened numerous years ago and he would have thought that the facility would have reported it to the fda when it initially occurred. Currently he was just calling due to wanting information for the mri. He does not want to provide any information; he will speak to the facility and call back tomorrow. Multiple attempts to contact the customer have been made without any additional information provided.
 
Manufacturer Narrative
(b)(4). Inadvertently omitted from initial submission. If further information becomes available a follow up medwatch will be submitted.
 
Manufacturer Narrative
(b)(4): one (1) nl3785-16 rhoton ball dissector 3mm 90deg 7-1/2in was reported in the complaint. The sample was not returned for evaluations and no pictures were sent or attached. The customer reported the sample¿s tip broke inside and has been retained inside the body. The customer also inquired if the broken part of the sample was magnetic for mri purposes. The broken complaint cannot be evaluated without sample analysis. The lot code was not reported and is not known on the nl3785-16 sample. The root cause of the reported failure mode cannot be confirmed without sample evaluation. Pertaining to the customer¿s question on the magnetic properties of the nl3785-16 sample. It was investigated to be magnetic as the product¿s material is created from 400 series stainless steel. Conclusion(s): no samples were returned for evaluations and verifications. The root cause could not be determined. Processes were reviewed to indicate proper manufacturing.
 
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Brand NameRHOTON BALL DISSECTOR 3MM 90DEG 7-1/2IN
Type of DeviceRONGEUR, MANUAL
Manufacturer (Section D)
CAREFUSION, INC
75 north fairway drive
vernon hills IL 60061
Manufacturer (Section G)
CAREFUSION, INC
5 sunnen dr
st. louis MO 63143
Manufacturer Contact
anna wehrheim
75 north fairway drive
vernon hills, IL 60061
8473628063
MDR Report Key6022118
MDR Text Key57689125
Report Number1923569-2016-00033
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 other
Reporter Occupation Patient
Type of Report Initial,Followup,Followup
Report Date 12/14/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/12/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNL3785-16
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 Received12/14/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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