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Adverse Event Report

CODMAN & SHURTLEFF, INC. MALIS BIPOLAR FORCEPS DEVICE, ELECTROSURGICAL, CUTTING & COAG. & ACCES   back to search results
Catalog Number 80-1551
Event Type  Malfunction   Patient Outcome  Other;
Manufacturer Narrative

Visual examination of the returned bipolar forcep revealed it had been adulterated by the customer. The forcep's nylon sleeve and potting compound are not codman components. It was also observed that the delrin insulated stop that is located at the point where the user would hold the forcep in use was missing. This left a metal to metal contact that could have caused an electrical arc. An electrical cord that was returned with the complaint sample could not be tested as it is not a codman item. The complaint cannot be confirmed as the device has been adulterated by the customer.

 
Event Description

International affiliate reports the surgeon was burned by the bipolar forcep while using the device during a procedure. Affiliate has no information regarding surgeon's condition or treatment administered.

 
Manufacturer Narrative

See h10.

 
Manufacturer Narrative

The bipolar forcep has been returned for evaluation. Results will be forwarded to the fda upon completion of the evaluation.

 
Search Alerts/Recalls

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Brand NameMALIS BIPOLAR FORCEPS
Type of DeviceDEVICE, ELECTROSURGICAL, CUTTING & COAG. & ACCES
Baseline Brand NameMALIS BIPOLAR FORCEPS
Baseline Generic NameDEVICE, ELECTROSURGICAL, CUTTING & COAG & ACCES.
Baseline Catalogue Number80-1551
Baseline Device FamilyMALIS BIPOLAR FORCEPS
Baseline Device 510(K) NumberK963499
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed10/08/1996
Manufacturer (Section F)
CODMAN & SHURTLEFF, INC.
new bedford industrial park
new bedford MA 02745
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC.
new bedford industrial park
new bedford MA 02745
Manufacturer Contact
matthew king
325 paramount drive
raynham , MA 02767
(508) 828 -3106
Device Event Key355923
MDR Report Key366800
Event Key345863
Report Number1226348-2001-00204
Device Sequence Number1
Product CodeGEI
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/26/2001
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/18/2001
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number80-1551
Device LOT Number9603N
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/13/2001
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/26/2001
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/01/1996
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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