MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC BIPOLAR CORD, NON-STERILE, FORCEPS; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	BIPOLAR CORD, NON-STERILE, FORCEPS
Medical Device Problem Codes	Failure to Deliver Energy (1211); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Trackwise id (b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.Device discarded.
Event or Problem Description
Related to (b)(4).The hospital reported that during an endoscopic vein harvesting procedure, bipolar cord, non-sterile, forceps malfunctioned.A replacement cord was used to complete the procedure.No harm was done to the patient.
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure, bipolar cord, nonsterile, forceps malfunctioned.It did not provide energy from the beginning.A replacement cord was used to complete the procedure.No harm was done to the patient.
Additional Manufacturer Narrative
The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.Trackwise id#: (b)(4).
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Trackwise # (b)(4).
Additional Manufacturer Narrative
Trackwise # (b)(4).Updated section: b4, g4, g7, h2, h6, 10, h11 updated section: d10-corrected to - device was discarded h6-corrected to -device was discarded, h3- if other provide code -explain- corrected to -device was discarded the reported device is an oem device, therefore, a lot history review was not applicable.The product is not returning.A lot/serial number was not provided and the specific product lot/serial number cannot be identified from a ship history, therefore it is impossible to obtain a certificate of conformance.H3 other text : device discarded.
Event or Problem Description
N/a.

• Brand Name: BIPOLAR CORD, NON-STERILE, FORCEPS
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ
• MDR Report Key: 14459678
• Report Number: 2242352-2022-00427
• Device Sequence Number: 11882708
• Product Code: GEI
• UDI-Device Identifier: 00607567700888
• UDI-Public: 00607567700888
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/13/2023

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: BIPOLAR CORD, NON-STERILE, FORCEPS
• Device Catalogue Number: C-1837
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2022
• Supplement Date Received by Manufacturer: 05/19/2022; 09/21/2022; 04/13/2023
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 06/08/2022; 10/17/2022; 04/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Male