TC METZENBAUM SCISSORS DEL CVD 230MM BC277R

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 2019-04-03 for TC METZENBAUM SCISSORS DEL CVD 230MM BC277R manufactured by Aesculap Ag.

Event Text Entries

[144974187] (b)(4). We received a complaint about seven pairs of scissors. According to the customer, the pairs of scissors are no longer cutting according to the desired quality. Furthermore, there are ten pairs of scissors in the hospital labelled with bc275r but they are 230mm long instead of 200mm. According to the available information, there were no negative consequences for the patient. All provided pairs of scissors are in used condition. Vigilance investigator carried out the pictorial documentation visually and microscopically. The dimensions of all provided products were checked. The labelling of the two products of complaint is not correct. The scissors are 230mm long instead of 200mm. Tus, they should have been labelled with the ref bc277r. All other provided scissors are labelled correctly. According to the q-coordinator of the production plant, quality assurance analyzed the case of mislabeling scissors bc275r. Orders bc275r and bc277r have been produced and released to laser marking department the same day. Most, likely the exchange of documentation did not take place during laser labeling and is traceable to an individual human mistake since the design of the scissors are very similar. A follow up training of all involved person will be initiated. Furthermore a cutting test was carried out. The insufficient cutting performance of the concerned products is most likely caused by wear and tear, due to the age and number of applications during this time. The device quality and manufacturing history records have been checked for all available lot numbers and found to be according to our specifications valid at the time of production. One similar incidents (wrong labelling) have been filed with products from batch 4507560233. No similar incidents (insufficient cutting) have been filed with products from these batches. Based on the information available as well as a result of our investigation the root cause of the wrong labelling is most probably related to a manufacturing error.
Patient Sequence No: 1, Text Type: N, H10


[144974188] It was reported by the healthcare professional "the wrong item numbers are on the scissors". All med watch submissions related to this are: 9610612-2019-00222 (this report), 9610612-2019-00223.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610612-2019-00222
MDR Report Key8478262
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2019-04-03
Date of Report2019-04-02
Date Facility Aware2019-03-28
Date Mfgr Received2019-03-11
Date Added to Maude2019-04-03
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 ContactMRS. NICOLE BROYLES
Manufacturer Street615 LAMBERT POINTE DRIVE
Manufacturer CityHAZELWOOD MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
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 METZENBAUM SCISSORS DEL CVD 230MM
Generic NameDUROTIP SCISSORS
Product CodeLRW
Date Received2019-04-03
Returned To Mfg2019-03-12
Model NumberBC277R
Catalog NumberBC277R
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerAESCULAP AG
Manufacturer AddressPO BOX 40 TUTTLINGEN, 78501 GM 78501


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-03

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