A1602, 6MM L/L STEALTH CLIP 1/4 F 10/BX 101374001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-02-19 for A1602, 6MM L/L STEALTH CLIP 1/4 F 10/BX 101374001 manufactured by Applied Medical Resources.

Event Text Entries

[180125404] The incident device is anticipated to return. A follow-up report will be provided upon completion of investigation.
Patient Sequence No: 1, Text Type: N, H10


[180125405] Procedure performed: ni. The clip remained blocked in the open position when the surgeon wanted to clamp the mammary artery. Clinical consequence: none. This incident took place at the ctcv block on (b)(6) 2020 and on (b)(6) 2020. Original : le clip est rest? Bloqu? En position ouverte lorsque le chirurgien a voulu clamper l'art? Re mammaire. Cons? Quence clinique : aucune. Cet incident a eu lieu au bloc ctcv le (b)(6) 2020 et le (b)(6) 2020. Intervention: ni. Patient status: clinical consequence: none.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2027111-2020-00370
MDR Report Key9730048
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2020-02-19
Date of Report2020-03-23
Date of Event2020-01-23
Date Mfgr Received2020-01-24
Device Manufacturer Date2019-07-05
Date Added to Maude2020-02-19
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 ContactWENDY KOBAYASHI
Manufacturer Street22872 AVENIDA EMPRESA
Manufacturer CityRANCHO SANTA MARGARITA CA 92688
Manufacturer CountryUS
Manufacturer Postal92688
Manufacturer Phone9497138059
Single Use3
Previous Use Code3
Removal Correction NumberNI
Event Type3
Type of Report3

Device Details

Brand NameA1602, 6MM L/L STEALTH CLIP 1/4 F 10/BX
Generic NameCLIP, VASCULAR
Product CodeDSS
Date Received2020-02-19
Model NumberA1602
Catalog Number101374001
Lot Number1360356
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerAPPLIED MEDICAL RESOURCES
Manufacturer Address22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA CA 92688 US 92688


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-19

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