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

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.

• Brand Name: RHOTON BALL DISSECTOR 3MM 90DEG 7-1/2IN
• Type of Device: RONGEUR, 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 Key: 6022118
• MDR Text Key: 57689125
• Report Number: 1923569-2016-00033
• Device Sequence Number: 1
• Product Code: HAE
• Combination Product (y/n): N
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NL3785-16
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/14/2016
• 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
• Patient Sequence Number: 1