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Adverse Event Report

ETHICON, INC. VERSAPOINT ELECTRODE   back to search results
Catalog Number 01985
Device Problem Perforation
Event Date 09/06/2000
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

It was reported that during a resection of fibroids the pt's uterus was perforated along with the sigmoid colon. The pt had been coughing during the procedure and moved their body twice. The physician is not sure if the vrs electrode or the curet caused the perforation. The pt was opened, cleaned and repaired. There was no sign of infection.

 
Manufacturer Narrative

Date submitted to fda: 10/6/2000. H-6 conclusion: no product malfunction reported. As stated in the instructions for use, which accompany each device, ". Care should be taken to avoid perforation of the uterus. " according to the details, as reported to co. The pt's movements may have contributed to this event.

 
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Brand NameVERSAPOINT
Type of DeviceELECTRODE
Baseline Brand NameVERSAPOINT
Baseline Generic NameELECTRODE
Baseline Catalogue Number01985
Baseline Device FamilyVERSAPOINT
Baseline Device 510(K) NumberK962482
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed07/08/1997
Manufacturer (Section F)
ETHICON, INC.
route 22 west
po box 151
somerville NJ 08876 0151
Manufacturer (Section D)
ETHICON, INC.
route 22 west
po box 151
somerville NJ 08876 0151
Manufacturer Contact
berkley pollard
rte 22 west
p.o. box 151
somerville , NJ 08876-0151
(908) 218 -2005
Device Event Key289619
MDR Report Key299199
Event Key281089
Report Number2210968-2000-00389
Device Sequence Number1
Product CodeJOS
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 09/08/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/06/2000
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number01985
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/06/2000
Device Ageunknown
Event Location Hospital
Date Manufacturer Received09/08/2000
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 Initial

Database last updated on February 28, 2009

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