OPMI PENTERO 000000-0480-801

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-12-15 for OPMI PENTERO 000000-0480-801 manufactured by Carl Zeiss Meditec Ag (oberkochen).

Event Text Entries

[95824452] Czmi made multiple attempts to obtain information regarding the surgery and the patient outcome. A response from hcp has not been received to date.
Patient Sequence No: 1, Text Type: N, H10


[95824453] The health care professional (hcp) reported that during a procedure the lamp of the opmi pentero system shut off and prompted an error message of "error defective lamp, 1282/-1157". A czmi technical support engineer (tse) advised hcp to switch to the backup lamp; however, the problem returned in a minute or two. The tse then advised hcp to switch to a back up microscope, if possible. It is unknown if microscope was actually swapped out during the procedure, as well as the outcome of the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9615010-2017-00018
MDR Report Key7123844
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2017-12-15
Date of Report2017-11-16
Date of Event2017-11-16
Date Mfgr Received2017-11-16
Device Manufacturer Date2008-12-10
Date Added to Maude2017-12-15
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationBIOMEDICAL ENGINEER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. WILLIAM GUSTAFSON
Manufacturer Street5160 HACIENDA DRIVE
Manufacturer CityDUBLIN CA 94568
Manufacturer CountryUS
Manufacturer Postal94568
Manufacturer Phone9255574689
Manufacturer G1CARL ZEISS MEDITEC AG (OBERKOCHEN)
Manufacturer StreetRUDOLF-EBER-STRASSE 11
Manufacturer CityOBERKOCHEN, BADEN-WUERTTEMBERG 73447
Manufacturer CountryGM
Manufacturer Postal Code73447
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOPMI PENTERO
Generic NameMICROSCOPE, SURGICAL, GENERAL & PLASTIC SURGERY
Product CodeFSO
Date Received2017-12-15
Model NumberNA
Catalog Number000000-0480-801
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCARL ZEISS MEDITEC AG (OBERKOCHEN)
Manufacturer AddressRUDOLF-EBER-STRASSE 11 OBERKOCHEN, BADEN-WUERTTEMBERG 73447 GM 73447


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-12-15

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