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Adverse Event Report

ERBE USA, INC. ERBE ICC 200 E/A ELECTROSURGICAL GENERATOR   back to search results
Model Number ICC 200 E/A
Device Problem Unknown (for use when the device problem is not known)
Event Date 06/05/2000
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

On 6-6-2000, an erbe sales representative, was informed of a required surgical intervention after a polypectomy with an electrosurgical generator. The generator was set in the "endocut" mode at a cut of 150 watts with a soft coag of 60 watts to remove a 2cm stalked polyp. After removing the polyp, the site bled and required surgery. Nurse stated that, "the polyp was too big to be resected and should have gone to surgery to have polyp removed. ".

 
Manufacturer Narrative

The settings for performing the procedure were appropriate per the suggested guideline. There was no report of the equipment malfunctioning. Hosp biomedical dept checked out equipment after the incident and found the unit to be working properly. No evidence was found with the system to indicate that there was/is a problem. No anomalies were found in a record review of the equipment. In conclusion, there was/is no evidence of a procedural problem or equipment malfunction. Polyp was very large. Gi lab supervisor stated that "polyp was to big to resected and should have gone to surgery to have polyp removed. " based upon the above info it appears that surgery to remove polyp and resection colon to control bleeding would have been the desired procedure. However, no definitive determination as to the cause of the event could be found. The customer will be notified of co's findings. No trends have been identified with this event. Erbe usa is now closing the file on this incident.

 
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Brand NameERBE ICC 200 E/A
Type of DeviceELECTROSURGICAL GENERATOR
Baseline Brand NameERBOTOM ICC 200 E/A
Baseline Generic NameELECTROSURGICAL GENERATOR
Baseline Catalogue Number10128-205
Baseline Model NumberICC 200 E/A
Baseline Device FamilyELECTRO. GEN. & ASSOC. EQUIP.
Baseline Device 510(K) NumberK933157
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed03/09/1994
Manufacturer (Section F)
ERBE USA, INC.
2225 northwest pkwy
marietta GA 30067
Manufacturer (Section D)
ERBE USA, INC.
2225 northwest pkwy
marietta GA 30067
Manufacturer Contact
john tartal
2225 northwest pkwy
marietta , GA 30067
(770) 955 -4400
Device Event Key274069
MDR Report Key283219
Event Key265659
Report Number9610614-2000-00007
Device Sequence Number1
Product CodeGEI
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 06/21/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/21/2000
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberICC 200 E/A
Device Catalogue Number10128-205
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/21/2000
Distributor Facility Aware Date06/05/2000
Device Age5 yr
Event Location Hospital
Date Report TO Manufacturer06/06/2000
Date Manufacturer Received06/06/2000
Was Device Evaluated By Manufacturer? No
Date Device Manufactured08/01/1999
Is The Device Single Use? 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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