TAKAHASHI NASAL FORCEPS *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-08-01 for TAKAHASHI NASAL FORCEPS * manufactured by Aesculap, Inc..

Event Text Entries

[15018876] While doing a septoplasty/turbinate reduction, the upper jaw of the takahashi ronguer broke off. Unable to visualize broken portion. Located on flat plate x-ray film. Attempted retrieval utilizing various resources, endoscopic attempt, c-arm assist, flexible scope. Called in another physician to assist. Unable to retrieve the broken portion. It was decided after approximately one hour of attempted retrieval to abort and finish procedure. Further retrieval to be attempted at a later date. What was the original intended procedure? Septoplasty. Device #1is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3291570
• MDR Report Key: 3291570
• Date Received: 2013-08-01
• Date of Report: 2013-08-01
• Date of Event: 2013-07-29
• Report Date: 2013-08-01
• Date Reported to FDA: 2013-08-01
• Date Reported to Mfgr: 2013-08-16
• Date Added to Maude: 2013-08-16
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: TAKAHASHI NASAL FORCEPS
• Generic Name: INSTRUMENT, RONGUER, ENT
• Product Code: EMH
• Date Received: 2013-08-01
• Model Number: TAKAHASHI NASAL FORCEPS
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: PHYSICIAN
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: AESCULAP, INC.
• Manufacturer Address: 3773 CORPORATE PKWY. CENTER VALLEY PA 18034 US 18034

Device Sequence Number: 2

• Brand Name: *
• Product Code: ---
• Date Received: 2013-08-01
• Device Sequence No: 2
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2013-08-01