ATR.UNI.FIX FORCEPS W/GROOVES D:5/310MM PO235R

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-30 for ATR.UNI.FIX FORCEPS W/GROOVES D:5/310MM PO235R manufactured by Aesculap Ag.

Event Text Entries

[186130814] 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


[186130815] It was reported that there was an issue with the forceps. According to the complaint description, the grip on the fenestrated grasper was not strong enough to grasp tissue. This caused the surgeon to tear a patient? S stomach. The procedure was a nissen fundoplication/ laparoscopic nissen. An additional medical intervention was necessary. Sutures were required and there was no detrimental harm (to be clarified). Patient was stable. Additional information has been requested but not yet received as of this report. The adverse event is filed under aag reference (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2916714-2020-00074
MDR Report Key9898197
Date Received2020-03-30
Date of Report2020-03-30
Date Facility Aware2020-03-10
Date Added to Maude2020-03-30
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameATR.UNI.FIX FORCEPS W/GROOVES D:5/310MM
Generic NameLAPAROSCOPIC SURGERY
Product CodeGEI
Date Received2020-03-30
Model NumberPO235R
Catalog NumberPO235R
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerAESCULAP AG
Manufacturer AddressPO BOX 40 TUTTLINGEN, 78501 GM 78501


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-30

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