MAUDE Adverse Event Report: CAREFUSION, INC DECKER RONGEUR CUP 2 X 6MM STR 6IN

Model Number NL6250

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/31/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4) on 31aug2017, 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

Customer stated via maude review: v mueller rongeur forceps nl6250 was in use for a surgical case.During the procedure, the small section that moves up and down to clamp tissue broke off.The surgeon was able to retrieve the broken piece without harm to patient.No further information available.

Manufacturer Narrative

(b)(4) the sample was not provided so an evaluation was performed based upon photos and information provided by the customer.The photos show that the upper part of the jaw has broken off.The loose part is visible in photo.Dhr and stock were checked and no abnormalities could be detected.Hardness values are in tolerance.Further examinations cannot be carried out because the instrument is physically not available.The most likely cause of the damage is improper use.The instrument is intended for grasping and cutting of soft tissue in the ent area.There have been no issues identified with the material or manufacturing process.A review of the device history records (dhr) did not identify and issues that would have contributed to the reported issue.

• Brand Name: DECKER RONGEUR CUP 2 X 6MM STR 6IN
• Type of Device: RONGEUR
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: anna wehrheim ; 75 north fairway drive; vernon hills, IL 60061
• MDR Report Key: 6878408
• MDR Text Key: 87769547
• Report Number: 1423507-2017-00099
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NL6250
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/30/2017
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention