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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMERICAN BIOSURGICAL, LLC AMERICAN BIOSURGICAL; BIPOLAR CORD 12FT DISP CLEAR NS
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AMERICAN BIOSURGICAL, LLC AMERICAN BIOSURGICAL; BIPOLAR CORD 12FT DISP CLEAR NS Back to Search Results
Model Number AB 1000-C-NS
Health Effect - Clinical Code Arrhythmia (1721)
Date of Event 05/19/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Roi cps, llc received the information related to this report through a customer complaint.Roi cps, llc is a procedure kit manufacturer.The reported device is contained, as a component, within roi kit 800756004, lot number 87847d.The incident was reported to the manufacturer of the bipolar cord.
 
Event or Problem Description
The patient has a pacemaker so the bipolar should not interfere with its function.When the surgeon used the bipolar, the patient started having arrhythmias.The surgeon discontinued using it, switched to a different bipolar cord and no further arrhythmias were noted.We are not sure if the cord was responsible, but it is suspicious.
 
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Brand Name
AMERICAN BIOSURGICAL
Common Device Name
BIPOLAR CORD 12FT DISP CLEAR NS
Manufacturer (Section D)
AMERICAN BIOSURGICAL, LLC
1850 beaver ridge cir #b
norcross GA 30071
MDR Report Key11903185
Report Number3014527682-2021-00006
Device Sequence Number17253173
Product Code GEI
UDI-Device Identifier10852028007021
UDI-Public10852028007021
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K953889
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 05/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberAB 1000-C-NS
Device Catalogue NumberAB 1000-C-NS
Device Lot Number2020030025
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/20/2021
Initial Report FDA Received Date05/28/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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