GRIESHABER REVOLUTION DSP FORCEPS 705.44P

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-04 for GRIESHABER REVOLUTION DSP FORCEPS 705.44P manufactured by Alcon Grieshaber Ag.

Event Text Entries

[182341723] No sample has been received by manufacturing for evaluation. Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[182341724] A health professional reported that an ophthalmic forceps device became clamped shut and would not open during surgery. Patient impact information is unknown. Additional information has been requested. Additional information received clarified that the unsatisfactory forceps would not reopen during a vitrectomy procedure. An alternate forceps was obtained in order to successfully complete the procedure. There was no harm to the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003398873-2020-00013
MDR Report Key9664350
Report SourceHEALTH PROFESSIONAL
Date Received2020-02-04
Date of Report2020-02-04
Date of Event2020-01-21
Date Mfgr Received2020-01-22
Device Manufacturer Date2019-01-11
Date Added to Maude2020-02-04
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. JASON MICHAELIDES
Manufacturer Street6201 SOUTH FREEWAY MAIL STOP AB2-6
Manufacturer CityFORT WORTH TX 76134
Manufacturer CountryUS
Manufacturer Postal76134
Manufacturer Phone8175686438
Manufacturer G1ALCON GRIESHABER AG
Manufacturer StreetWINKELRIEDSTRASSE 52
Manufacturer CitySCHAFFHAUSEN 8203
Manufacturer CountrySZ
Manufacturer Postal Code8203
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameGRIESHABER REVOLUTION DSP FORCEPS
Generic NameFORCEPS, OPHTHALMIC
Product CodeHNR
Date Received2020-02-04
Model NumberNA
Catalog Number705.44P
Lot Number278496M
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerALCON GRIESHABER AG
Manufacturer AddressWINKELRIEDSTRASSE 52 SCHAFFHAUSEN 8203 SZ 8203


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-04

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