MINOP REPLACEMENT PART F/FF388R FF438R

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 2020-02-20 for MINOP REPLACEMENT PART F/FF388R FF438R manufactured by Aesculap Ag.

Event Text Entries

[181641591] Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10


[181641592] It was reported that there was an issue with minop replacement part. According to the customer report: "item tip broke off during surgery. Broken piece was retrieved and medical imaging contacted:" this incident did not cause or contribute to serious injury or death. There was a delay in critical therapy. An additional medical intervention was necessary. The adverse event is filed under (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610612-2019-00965
MDR Report Key9732988
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-02-20
Date of Report2020-02-20
Date of Event2020-01-25
Date Mfgr Received2020-01-28
Date Added to Maude2020-02-20
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 KERSTIN ROTHWEILER
Manufacturer StreetPO BOX 40
Manufacturer CityTUTTLINGEN, 78501
Manufacturer CountryGM
Manufacturer Postal78501
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 NameMINOP REPLACEMENT PART F/FF388R
Generic NameOR TECHNOLOGY NEURO
Product CodeGWG
Date Received2020-02-20
Returned To Mfg2020-02-13
Model NumberFF438R
Catalog NumberFF438R
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
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. Required No Informationntervention 2020-02-20

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