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Adverse Event Report

ETHICON ENDO SURGERY, INC. (CINCINNATI) PROXIMATE HSC (PPH) SET   back to search results
Catalog Number PPH01
Event Date 02/06/2004
Event Type  Malfunction   Patient Outcome  Other;
Event Description

It was reported that during a bowel resection procedure, the dr would not break the washer due to the high force to fire. He found that posterior wall did not cut completely. The dr cut the tissue transanally. Staple formation was ok. Dr put some overstitches. There was no pt consequence.

 
Manufacturer Narrative

D5; h4, 6: info anticipated, but unavailable at this time.

 
Search Alerts/Recalls

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Brand NamePROXIMATE HSC (PPH) SET
Type of DevicePROXIMATE HSC (PPH) SET
Baseline Brand NamePROXIMATE HCS HEMORROIDAL
Baseline Generic NameCIRCULAR STAPLERS
Baseline Catalogue NumberPPH01
Baseline Device FamilyCIRCULAR STAPLERS
Baseline Device 510(K) NumberK801154
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)60
Date First Marketed06/20/1980
Manufacturer (Section F)
ETHICON ENDO SURGERY, INC. (CINCINNATI)
4545 creek rd.
cincinnati OH 45242 2803
Manufacturer (Section D)
ETHICON ENDO SURGERY, INC. (CINCINNATI)
4545 creek rd.
cincinnati OH 45242 2803
Manufacturer (Section G)
ETHICON ENDO SURGERY, INC. (TORRES)
avenida de las torres
7125 parque
ciudad juarez chihuahua
MEXICO
Manufacturer Contact
gary leblanc
4545 creek rd
cincinnati , OH 45242-2803
(513) 337 -8582
Device Event Key518959
MDR Report Key529730
Event Key502872
Report Number1527736-2004-00503
Device Sequence Number1
Product CodeKOG
Report Source Manufacturer
Source Type Foreign,Health Professional,User facility,Company Representative
Reporter Occupation Other
Remedial Action Other
Type of Report Initial
Report Date 02/09/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/03/2004
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberPPH01
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Device Ageunknown
Event Location Not Applicable
Date Manufacturer Received02/09/2004
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown

Database last updated on January 30, 2009

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