GRIESHABER REVOLUTION DSP SCISSORS 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 2017-07-12 for GRIESHABER REVOLUTION DSP SCISSORS 705.52P manufactured by Alcon Grieshaber Ag.

Event Text Entries

[79952632] A sample is available that has not yet been received by manufacturing for evaluation. The device history record for the affected lot was reviewed. No abnormalities that could have contributed to this event were found in the production documentation and the sample was released according to acceptance criteria. 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. A 100% final inspection for this product. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[79952633] A doctor reported that an ophthalmic scissors was unable to close prior to surgery. There was no patient involvement therefore, no impact to any patient. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003398873-2017-00019
MDR Report Key6708599
Date Received2017-07-12
Date of Report2017-10-03
Date of Event2017-06-28
Date Mfgr Received2017-09-20
Device Manufacturer Date2016-05-18
Date Added to Maude2017-07-12
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. NADIA BAILEY
Manufacturer Street6201 SOUTH FREEWAY MAIL STOP AB2-6
Manufacturer CityFORT WORTH TX 76134
Manufacturer CountryUS
Manufacturer Postal76134
Manufacturer Phone8176152230
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 Report0

Device Details

Brand NameGRIESHABER REVOLUTION DSP SCISSORS
Generic NameSCISSORS, OPHTHALMIC
Product CodeHNF
Date Received2017-07-12
Returned To Mfg2017-07-25
Model NumberNA
Catalog Number705.52P
Lot NumberF137902
Device Expiration Date2019-04-30
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
101. Other 2017-07-12

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