AUTO-IRIS FIBER LIGHT PROJECTOR 5119.00

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-05-22 for AUTO-IRIS FIBER LIGHT PROJECTOR 5119.00 manufactured by Richard Wolf Medical Instrume..

Event Text Entries

[54749] A surgical procedure was being done using a fiber light retractor, light cable and light source. The connection between the retractor and the cable was not enough to cause a 1cm minor skin burn when the two were inadvertently left on the pt. The burn was treated with ointment and an adhesive bandage strip. The user was aware that the fiber light source generator had operating instructions that indicate that light connectors can get hot enough to cause burns and care must be taken during use.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1418479-1997-00025
MDR Report Key93557
Report Source05,06
Date Received1997-05-22
Date of Report1997-04-23
Date of Event1997-04-17
Report Date1997-04-23
Date Reported to FDA1997-04-23
Date Reported to Mfgr1997-04-23
Date Mfgr Received1997-04-23
Device Manufacturer Date1990-08-01
Date Added to Maude1997-05-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameAUTO-IRIS FIBER LIGHT PROJECTOR
Generic NameFIBER LIGHT PROJECTOR
Product CodeFCR
Date Received1997-05-22
Model Number5119.00
Catalog Number5119.00
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age7 YR
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key85205
ManufacturerRICHARD WOLF MEDICAL INSTRUME.
Manufacturer Address353 CORPORATE WOODS BLVD. VERNON HILLS IL 60061 US
Baseline Brand NameAUTO-IRIS FIBER LIGHT PROJECTOR
Baseline Generic NameFIBER LIGHT PROJECTOR
Baseline Model No5119.00
Baseline Catalog No5119.00
Baseline ID867
Baseline Device FamilyFIBER LIGHT PROJECTOR
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNN
Baseline PreamendmentY
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
10 1997-05-22

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