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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG PAS-PORT PROXIMAL ANASTOMOSIS DEVICE; ANASTOMOSIS DEVICES
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AESCULAP AG PAS-PORT PROXIMAL ANASTOMOSIS DEVICE; ANASTOMOSIS DEVICES Back to Search Results
Model Number FG-000001-14
Device Problem Compatibility Problem (2960)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/08/2020
Event Type  malfunction  
Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
 
Event Description
It was reported that there was an issue with product a pas-port proximal anastomosis device.After deployment, blood leaked from the anastomosed site.There was oozing blood; after that, it stopped without any dealing.The patient condition is stable after the procedure.The surgeon said the oozing blood was probably no problem.There was no patient harm.Additional information has been requested but not yet received as of this report.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).
 
Manufacturer Narrative
The reportability was reassessed and found to no longer require submission - aesculap is not the legal manufacturer of this device.
 
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Brand Name
PAS-PORT PROXIMAL ANASTOMOSIS DEVICE
Type of Device
ANASTOMOSIS DEVICES
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM  78501
MDR Report Key10303095
MDR Text Key199740613
Report Number9610612-2020-00311
Device Sequence Number1
Product Code FZP
Combination Product (y/n)N
PMA/PMN Number
K091017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/20/2021
Device Model NumberFG-000001-14
Device Catalogue NumberFG-000001-14
Device Lot Number191014E
Was Device Available for Evaluation? No
Date Manufacturer Received10/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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