TC NELSON-METZ SCISSORS DEL CVD 285MM BC281R

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-05-07 for TC NELSON-METZ SCISSORS DEL CVD 285MM BC281R manufactured by Aesculap Ag.

Event Text Entries

[144969631] (b)(4). Preliminary investigation: a visual inspection of the instrument and of the fracture surface. The instrument was sent to the production department for further investigation. The report will be updated when we receive a statement from the production department. Batch history review: the device quality and manufacturing history records will be checked for the lot number 4509144704 from the quality coordinator of the production plant. After review, the report will be updated. No similar incidents have been filed with products from this batch. Conclusion and root cause: the root cause could be manufacturing related. The report will be updated when we receive a statement from the production department. Rationale: due to the circumstance that the product has been sent to the manufacturer for an analysis this is a preliminary report and it will be updated when we receive a statement from the manufacturer. Investigations lead to the assumption that the scissor part was damaged before soldering the carbide due to the signs of soldering deposits. There is also the possibility that the scissor part was not completely pronounced or was damaged during production. We are currently unable to determine any fracture surface. When additional information is received a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[144969634] It was reported a missing piece was seen on scissor blade. The reporter indicated that during the packing process it was noticed that a piece of the blade broke off. It is unknown where the broken part is located. Per the reporter, the broken piece was so small that it was noticed only during the packaging process and unfortunately not earlier and it is possible that this could have happened weeks ago. No additional information has been provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610612-2019-00307
MDR Report Key8588936
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-05-07
Date of Report2019-06-17
Date of Event2019-04-10
Date Facility Aware2019-06-03
Date Mfgr Received2019-06-03
Device Manufacturer Date2017-12-08
Date Added to Maude2019-05-07
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. LINDSAY CHROMIAK
Manufacturer Street3773 CORPORATE PARKWAY
Manufacturer CityCENTER VALLEY PA 18034
Manufacturer CountryUS
Manufacturer Postal18034
Manufacturer Phone8002581946
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 NELSON-METZ SCISSORS DEL CVD 285MM
Generic NameBASIC INSTRUMENTS
Product CodeLRW
Date Received2019-05-07
Returned To Mfg2019-04-17
Model NumberBC281R
Catalog NumberBC281R
Lot Number4509144704
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
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 2019-05-07

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