MID LABS 2540CE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2012-05-11 for MID LABS 2540CE manufactured by Medical Instrument Development Laboratories, Inc..

Event Text Entries

[2712843] Dr tried two cutters of 2540ce both in the same lot and they would not cut. They didn't do anything. They did have pt contact, but no injury. Cutters were tested prior to surgery and worked. When surgery started the cutter sounded like it was working but was not cutting. Aspiration continued. They tried the 20 gauge they had on hand and it worked. They borrowed a 25 gauge from the hosp with a different lot number and they also worked.
Patient Sequence No: 1, Text Type: D, B5


[9889857] Device eval summary: report: vitreous cutter did not cut. Analysis: vitreous cutter was returned bent. Vitreous cutter tested and inspected and did not meet cut test specification due to the vitreous cutter being bent.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2935428-2012-00002
MDR Report Key2584901
Report Source08
Date Received2012-05-11
Date of Report2012-05-11
Date of Event2012-04-12
Date Mfgr Received2012-04-13
Device Manufacturer Date2011-09-01
Date Added to Maude2012-09-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer Street557 MC CORMICK STREET
Manufacturer CitySAN LEANDRO CA 94577
Manufacturer CountryUS
Manufacturer Postal94577
Manufacturer Phone5103573952
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMID LABS
Generic NameVITREOUS CUTTER
Product CodeMLZ
Date Received2012-05-11
Returned To Mfg2012-05-08
Catalog Number2540CE
Lot Number11070508
Device Expiration Date2014-09-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.
Manufacturer AddressSAN LEANDRO CA 94577 US 94577


Patients

Patient NumberTreatmentOutcomeDate
10 2012-05-11

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