C8322, XS ALEXIS WND PROT/RET SHRT 5/BX 4

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-07-06 for C8322, XS ALEXIS WND PROT/RET SHRT 5/BX 4 manufactured by Applied Medical Resources.

Event Text Entries

[79236096] No product is being returned for evaluation and no lot # has been provided to manufacturer. A follow up report will be sent once the results have been analyzed.
Patient Sequence No: 1, Text Type: N, H10


[79236097] Procedure performed: vats. Event description: alexis tearing at (b)(6) in cardio thoracic cases. They have had 7 alexis tears in these cases. [surgeon] communicated the following regarding the device along with suggestions: -the device is tearing during insertion and removal, and not all the time. -the device placement is the same and this is occurring during vat procedures. -he is rolling the device outward as indicated. -he admitted the tearing of the plastic sheath is often caused by poking it with an object (even his own finger). One device is returning on cer (2017-1091). The other cers have no product returning (2017-1100/1101/1102/1103/1104/1105). Additional information received via telephone from [applied medical team member #1] on june 19, 2017 - it is unsure if the alexis model used was the c8312 or the c8322, but it is believed to be the regular xs alexis (c8312). The other products from the other cases are not available as they were disposed. Additional info received via telephone from [applied medical team member #1] and [applied medical team member #2] on june 26, 2017 - it was confirmed the product for this cer was the xx small alexis (c8323). The rest of the events have been used with the xs short alexis (c8322). It was mentioned that the tears occur during removal of the flexible ring. The surgeon explained it is difficult to get his finger around the ring to pull it out and is tearing as a result. It is tearing intraabdominally within the intercostal area above the flexible ring. According to the doctor, the reason the device is being rolled outward instead of inward because this gives the surgeon extra space when removing.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2027111-2017-01883
MDR Report Key6691880
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2017-07-06
Date of Report2017-09-05
Date Mfgr Received2017-06-15
Date Added to Maude2017-07-06
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 NumberNA
Event Type3
Type of Report3

Device Details

Brand NameC8322, XS ALEXIS WND PROT/RET SHRT 5/BX
Generic NameKGW
Product CodeKGW
Date Received2017-07-06
Model Number4
Catalog Number4
Lot NumberUNK
Device AvailabilityN
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 2017-07-06

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