BROWN-ADSN FCPS 4-3/4 7X7 6-124

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-08-11 for BROWN-ADSN FCPS 4-3/4 7X7 6-124 manufactured by Integra York, Pa Inc..

Event Text Entries

[82912076] On 8/7/2017 integra investigation completed. Method: failure analysis, device history evaluation. Results: failure analysis - failure analysis cannot be completed due to the lack of information received to perform a complete investigation. Product has not been returned for evaluation. Unconfirmed. Device history evaluation - nonconforming product report / nonconforming material report history: none. Variance authorization / deviation history: none. Engineering change order/manufacturing change order history: there is no applicable. Engineering change order/manufacturing change order history. Corrective action preventive action history/corrections: none. Health hazard evaluation history: none. Conclusion: root cause cannot be determined due to the lack of information received to perform a complete investigation. Product has not been returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10


[82912077] Customer mw 5070582 reports a patient in operating room for partial left partial left 2nd digit amputation. After the procedure central sterile personnel were cleaning the instrument and noticed one tooth of the miltex #6-124 brown-adson tissue forceps was missing. A post op x_ray had already been taken. No radiopaque foreign bodies were seen. No harm to patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2523190-2017-00083
MDR Report Key6789059
Report SourceUSER FACILITY
Date Received2017-08-11
Date of Report2017-07-14
Date of Event2017-06-20
Date Mfgr Received2017-07-14
Date Added to Maude2017-08-11
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 ContactUSER SANDRA LEE
Manufacturer Street311 ENTERPRISE DRIVE
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal08536
Manufacturer Phone6099362393
Manufacturer G1INTEGRA YORK, PA INC.
Manufacturer Street589 DAVIES DRIVE
Manufacturer CityYORK PA 17402
Manufacturer CountryUS
Manufacturer Postal Code17402
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBROWN-ADSN FCPS 4-3/4 7X7
Generic NameM5 - GENERAL SURGERY
Product CodeGEN
Date Received2017-08-11
Catalog Number6-124
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerINTEGRA YORK, PA INC.
Manufacturer Address589 DAVIES DRIVE 589 DAVIES DRIVE YORK PA 17402 US 17402


Patients

Patient NumberTreatmentOutcomeDate
10 2017-08-11

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