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Adverse Event Report

ENCISION, INC. AEM FIXED TIP ELECTRODE, 5MM REUSABLE - J-HOOK LAPAROSCOPIC ELECTROSURGICAL DEVICE   back to search results
Model Number ES3510B
Event Date 09/05/2001
Event Type  Malfunction   Patient Outcome  Other;
Event Description

The sales representative reported the tips broke off two j-hook electrodes. One was during a procedure, but the tip was retrieved from the patient and no serious injury was reported.

 
Manufacturer Narrative

No additional investigation because problem is known and previously evaluated.

 
Search Alerts/Recalls

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Brand NameAEM FIXED TIP ELECTRODE, 5MM REUSABLE - J-HOOK
Type of DeviceLAPAROSCOPIC ELECTROSURGICAL DEVICE
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
ENCISION, INC.
4828 sterling dr.
boulder CO 80301
Manufacturer (Section D)
ENCISION, INC.
4828 sterling dr.
boulder CO 80301
Manufacturer Contact
judith king
4828 sterling dr.
boulder , CO 80301
(303) 440 -9250 ext 117
Device Event Key342709
MDR Report Key353473
Event Key333035
Report Number1722040-2001-00010
Device Sequence Number1
Product CodeGEI
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 09/21/2001
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/24/2001
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberES3510B
Device Catalogue NumberES3510B
Device LOT NumberGB
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/08/2001
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received09/05/2001
Was Device Evaluated By Manufacturer? No
Date Device Manufactured02/01/2001
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 February 28, 2009

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