MAUDE Adverse Event Report: AMERICAN BIO-SURGICAL (AMC) AMERICAN BIO-SURGICAL (AMC); CORD BIPOLAR 12FT

Model Number	AB1000-B-NS
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The electrical end of the bipolar cord, that plugs into the generator, keeps falling out rendering the bipolar forceps unusable for cauterizing vessels.

• Brand Name: AMERICAN BIO-SURGICAL (AMC)
• Common Device Name: CORD BIPOLAR 12FT
• Manufacturer (Section D): AMERICAN BIO-SURGICAL (AMC); 1850 beaver ridge cir # b; norcross GA 30071
• Manufacturer (Section G): ROI CPS, LLC; 3000 east sawyer road; republic MO 65738
• Manufacturer Contact: cheyenne stewart ; 3000 east sawyer road; republic, MO 65738 ; 4176473205
• MDR Report Key: 15915821
• Report Number: 3014527682-2022-00011
• Device Sequence Number: 4347545
• Product Code: GEI
• UDI-Device Identifier: 10852028007007
• UDI-Public: 10852028007007
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/05/2022

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 Number: AB1000-B-NS
• Device Catalogue Number: AB1000-B-NS
• Device Lot Number: 2021110099;2022010008
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2022
• Initial Report FDA Received Date: 12/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown