GRIESHABER REVOLUTION DSP FORCEPS 705.52P

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-25 for GRIESHABER REVOLUTION DSP FORCEPS 705.52P manufactured by Alcon Grieshaber Ag.

Event Text Entries

[143389616] 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[143389637] A nurse reported that an ophthalmic forceps could not be opened prior to surgery. An alternate forceps was obtained in order to begin and perform the procedure. There was no patient impact associated with this reported event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003398873-2019-00032
MDR Report Key8553347
Date Received2019-04-25
Date of Report2019-11-29
Date of Event2019-04-12
Date Mfgr Received2019-11-14
Device Manufacturer Date2018-08-09
Date Added to Maude2019-04-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. CINDY MILAM
Manufacturer Street6201 SOUTH FREEWAY MAIL STOP AB2-6
Manufacturer CityFORT WORTH TX 76134
Manufacturer CountryUS
Manufacturer Postal76134
Manufacturer Phone8176152231
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 NameSCISSORS, OPHTHALMIC
Product CodeHNF
Date Received2019-04-25
Returned To Mfg2019-04-24
Model NumberNA
Catalog Number705.52P
Lot NumberF167692
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerALCON GRIESHABER AG
Manufacturer AddressWINKELRIEDSTRASSE 52 SCHAFFHAUSEN 8203 SZ 8203


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-25

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