PURSE STRING CLAMP EA323R

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-03 for PURSE STRING CLAMP EA323R manufactured by Aesculap Ag.

Event Text Entries

[71735380] (b)(4). Manufacturing site evaluation: evaluation on-going
Patient Sequence No: 1, Text Type: N, H10


[71735381] (b)(6). It was reported that the forceps (purse string clamp was used for surgery. The suture did not hold, the forceps did not function properly. New operation was necessary due to lesion. All med watch submissions related to this report are: 9610612-2017-00177, 9610612-2017-00185. Incident was reported by the same initial reporter by mdrs: 9610612-2017-00083 and 9610612-2017-00093. Its unknown if these were used on the same patient with information reported.
Patient Sequence No: 1, Text Type: D, B5


[74932056] Investigation: the investigation was carried out by ats. The jaw parts are not flush and not fitting, thus the toothing is damaged. The clamp is not according to the specifications. Batch history review: the device quality and manufacturing history records have been checked for all available lot numbers. The device history file has been checked and found to be according to our specification valid at the time of production. No similar incidents have been filed with products from this batch. Conclusion and root cause: based on the information available as well as a result of our investigation the root cause of the failure is most probably a manufacturing error. Rational: according to the investigation of ats, the instruments is not according to the specifications. Corrective action: according to (b)(4) a capa is not necessary.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9610612-2017-00185
MDR Report Key6455134
Date Received2017-04-03
Date of Report2017-05-08
Date Facility Aware2017-03-20
Date Mfgr Received2017-03-08
Device Manufacturer Date2016-11-25
Date Added to Maude2017-04-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
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 NamePURSE STRING CLAMP
Generic NameGENERAL SURGICAL INSTRUMENTS
Product CodeFFN
Date Received2017-04-03
Returned To Mfg2017-03-16
Model NumberEA323R
Catalog NumberEA323R
Lot Number4508191826
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Age4 MO
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerAESCULAP AG
Manufacturer AddressPO BOX 40 TUTTLINGEN, 78501 GM 78501


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-04-03

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