JAMESON TENOTOMY SCISSDELCVDB/B150MM BC177R

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 2019-05-07 for JAMESON TENOTOMY SCISSDELCVDB/B150MM BC177R manufactured by Aesculap Ag.

Event Text Entries

[144969507] (b)(4). Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report. Investigation on-going.
Patient Sequence No: 1, Text Type: N, H10


[144969508] It was reported that there was an issue with the tenotomy scissors. During surgery, the scissors was noted to have pitting. This was viewed under the microscope and they were being used the first time. No additional intervention was required and there was no patient harm. There may have been a short delay in surgery. Another pair of scissors was used instead. Additional information was not available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610612-2019-00310
MDR Report Key8587962
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-05-07
Date of Report2019-07-29
Date of Event2019-04-12
Date Facility Aware2019-04-30
Date Mfgr Received2019-07-01
Device Manufacturer Date2018-08-16
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. KERSTIN ROTHWEILER
Manufacturer StreetPO BOX 40
Manufacturer CityTUTTLINGEN, MO 78501
Manufacturer CountryGM
Manufacturer Postal78501
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 NameJAMESON TENOTOMY SCISSDELCVDB/B150MM
Generic NameBASIC INSTRUMENTS
Product CodeLRW
Date Received2019-05-07
Returned To Mfg2019-04-26
Model NumberBC177R
Catalog NumberBC177R
Lot Number4509839109
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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