TC MAYO-LEXER SCISSORS CVD 165MM BC284R

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-01-08 for TC MAYO-LEXER SCISSORS CVD 165MM BC284R manufactured by Aesculap Ag.

Event Text Entries

[132362484] (b)(4). The instrument is not available for investigation. The product does not require batch management; a review of the device quality and manufacturing history records is not possible. No product available and therefore it is not possible to determine an exact conclusion and root cause. We assume that the cause of the failure is not product related. There is the possibility that the root cause of the problem is most probably usage related. Due to a lack of data and without the product not determine the exact cause. There is the possibility for a usage error due to a mechanical overload situation. If further investigations are required, the product should be provided for examination.
Patient Sequence No: 1, Text Type: N, H10


[132362565] During a surgical procedure a piece from the surgical instrument broke off at the outer edge of the chisel. The piece measures about 1mm long and about 0. 5mm wide. At the time of the surgery, particles fell in the patient's scar. Medical device fragments remained in the patient. When additional information is received a follow up report will be submitted.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610612-2019-00006
MDR Report Key8226410
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2019-01-08
Date of Report2018-01-08
Date of Event2018-11-30
Date Facility Aware2018-12-21
Date Mfgr Received2018-12-11
Date Added to Maude2019-01-08
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. NICOLE BROYLES
Manufacturer Street615 LAMBERT POINTE DRIVE
Manufacturer CityHAZELWOOD MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
Manufacturer Phone3145515988
Manufacturer G1AESCULAP AG
Manufacturer StreetPO BOX 40
Manufacturer CityTUTTLINGEN, 78501
Manufacturer CountryGM
Manufacturer Postal Code78501
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTC MAYO-LEXER SCISSORS CVD 165MM
Generic NameDUROTIP SCISSORS
Product CodeLRW
Date Received2019-01-08
Model NumberBC284R
Catalog NumberBC284R
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerAESCULAP AG
Manufacturer AddressPO BOX 40 TUTTLINGEN, 78501 GM 78501


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-01-08

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.