MURDOCK LID SPECULUM USING STILETTOS 23.5-GAUGE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-01-26 for MURDOCK LID SPECULUM USING STILETTOS 23.5-GAUGE * manufactured by Alcon Manufacturing, Ltd.

Event Text Entries

[569828] During the repair of retinal detachment by vitrectomy, right eye, the perfluoron was instilled and further trimming and shaving of the peripheral vitreous was performed. During this maneuver, the tip of the probe partially broke off, however, it could be removed from the patient's globe together with the super temporal sleeve. The sleeve was then inserted and the operation was continued. No foreign particles were noted in the eye during the examination and patient was discharged to the recovery room after tolerating the procedure very well.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	MW1041763
MDR Report Key	810624
Date Received	2007-01-26
Date of Report	2007-01-26
Date of Event	2006-12-19
Date Added to Maude	2007-02-01
Event Key	0
Report Source Code	Voluntary report
Manufacturer Link	N
Number of Patients in Event	0
Adverse Event Flag	3
Product Problem Flag	3
Reprocessed and Reused Flag	3
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 Details

Brand Name	MURDOCK LID SPECULUM USING STILETTOS 23.5-GAUGE
Generic Name	PROBE
Product Code	HNC
Date Received	2007-01-26
Returned To Mfg	2007-01-26
Model Number	*
Catalog Number	*
Lot Number	*
ID Number	*
Device Availability	R
Device Age	*
Implant Flag	N
Date Removed	*
Device Sequence No	1
Device Event Key	798081
Manufacturer	ALCON MANUFACTURING, LTD
Manufacturer Address	158 ALTON PARKWAY IRVINE CA 92618 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Deathisabilit	2007-01-26