MAUDE Adverse Event Report: STOERK GMBH COTTLE SEPTUM ELEVATOR 9IN SS; ELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number 88-3873

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/19/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This complaint was opened from a report received through the maude report and contains no contact or facility information, so further information is unavailable.

Event Description

Maude report states, "cottle elevator used in ent surgery broke during sinus surgery.The surgeon retrieved the broken piece with no harm to the patient." the device and lot number are not available.No further information.

• Brand Name: COTTLE SEPTUM ELEVATOR 9IN SS
• Type of Device: ELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STOERK GMBH; engenerstr. 11; emmingen 78576 ; GM 78576
• 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: 6304787
• MDR Text Key: 66875343
• Report Number: 1423507-2017-00081
• Device Sequence Number: 1
• Product Code: KAD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,user facility
• Type of Report: Initial
• Report Date: 02/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 88-3873
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: N
• Patient Sequence Number: 1