MICROSURGICAL INSTRUMENT, 23GA. SOFT TIP NEEDLE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-07-03 for MICROSURGICAL INSTRUMENT, 23GA. SOFT TIP NEEDLE manufactured by Alconmedical Safety.

Event Text Entries

[21656121] Pt having a 23 gauge pars plana vitrectomy, right eye. Upon placing a 23g soft tip needle into a 23g cannula into the patient's eye, the surgeon noticed that the silicone soft tip was missing from the needle. The surgeon thoroughly searched the eye and surroundings. The silicone soft tip was found on the outside of the eye. No harm to the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5030817
MDR Report Key3216143
Date Received2013-07-03
Date of Report2013-07-03
Date of Event2013-06-12
Date Added to Maude2013-07-11
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameMICROSURGICAL INSTRUMENT, 23GA. SOFT TIP NEEDLE
Generic NameSOFT TIP NEEDLE
Product CodeHNM
Date Received2013-07-03
Lot Number925997M
ID NumberREF 8065149523
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerALCONMEDICAL SAFETY
Manufacturer Address6201 SOUTH FREEWAY MAIL CODE AB2-6 FORT WORTH TX 76134200 US 76134 2001


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2013-07-03

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