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Adverse Event Report

BARD ENDOSCOPIC TECHNOLOGIES, CR BARD LOW COST BIOPSY FORCEP   back to search results
Model Number 61 000569
Device Problem Component(s), detachment of
Event Date 09/28/2001
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

Dr. Placed forcep down the scope without any problems. When the doctor went to take the first bite, he then noticed that the needle broke off inside the patient (at the entrance of the stomach). The dr. Was able to retrieve the needle with the same forcep (without incident) but could not retract the needle and forcep into the channel of the scope. The forcep and needle were coaxially removed. This incident had no impact on the patient, therefore pt is doing fine.

 
Manufacturer Narrative

Product was returned without the needle. There was no evidence of any damage to the jaws or screw. The device history review revealed no discrepancies that would cause or contribute to the reported condition. The results are inconclusive due to the incomplete evaluation sample.

 
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Brand NameLOW COST BIOPSY FORCEP
Type of DeviceFORCEP
Baseline Brand NameLOW COST BIOPSY FORCEP
Baseline Generic NameFORCEP
Baseline Catalogue Number61 000569
Baseline Model Number61 000569
Baseline Device FamilyFORCEPS
Baseline Device 510(K) NumberK922086
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)24
Date First Marketed12/28/2000
Manufacturer (Section F)
BARD ENDOSCOPIC TECHNOLOGIES, CR BARD
129 concord road bldg. #3
billerica MA 01821
Manufacturer (Section D)
BARD ENDOSCOPIC TECHNOLOGIES, CR BARD
129 concord road bldg. #3
billerica MA 01821
Manufacturer Contact
nancy cutino
129 concord road bldg #3
billerica , MA 01821
(978) 663 -8989
Device Event Key348995
MDR Report Key359814
Event Key339132
Report Number1223688-2001-00052
Device Sequence Number1
Product CodeFCL
Report Source Manufacturer
Source Type Other
Reporter Occupation Other
Type of Report Initial
Report Date 10/22/2001,10/01/2001
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/26/2001
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date08/01/2003
Device MODEL Number61 000569
Device Catalogue Number61 000569
Device LOT Number88HL0489
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/08/2001
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/28/2001
Device Age2 mo
Event Location Outpatient DIAGNOSTIC Facility
Date Manufacturer Received10/01/2001
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/01/2001
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 January 30, 2009

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