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Adverse Event Report

ETHOX PRO46 ENDOPOUCH PRO SPECIMEN RETRIEVAL BAG   back to search results
Catalog Number PRO46
Event Type  Malfunction   Patient Outcome  Other;
Event Description

It was reported by the rep that the bag on the devices ripped. Opened another device to complete the case. There was no consequence to pt.

 
Manufacturer Narrative

D5; h4: info anticipated, but unavailable at this time.

 
Search Alerts/Recalls

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Brand NamePRO46 ENDOPOUCH PRO SPECIMEN RETRIEVAL BAG
Type of DeviceENDOPOUCH
Baseline Brand NameENDOPOUCH SPECIMEN RETRIEVAL BAG
Baseline Generic NamePOUCH
Baseline Catalogue NumberPRO46
Baseline Device FamilyENDOSCOPIC SURGICAL SPECIMEN BAG
Baseline Device 510(K) NumberK981579
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)36
Date First Marketed09/09/1998
Manufacturer (Section F)
ETHOX
251 seneca st
buffalo NY 14204
Manufacturer (Section D)
ETHOX
251 seneca st
buffalo NY 14204
Manufacturer Contact
tom bosticco, mgr
4545 creek rd
cincinnati , OH 45242
(513) 337 -8935
Device Event Key316750
MDR Report Key327357
Event Key308054
Report Number1527736-2001-01831
Device Sequence Number1
Product CodeMDM
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Nurse
Remedial Action Other
Type of Report Initial
Report Date 03/14/2001
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/12/2001
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberPRO46
Device LOT Number00D553
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location Not Applicable
Date Manufacturer Received03/14/2001
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown

Database last updated on February 28, 2009

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