MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC DC EXTENSION CABLE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	DC EXTENSION CABLE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Related to (b)(4).The hospital reported that during preparation for an endoscopic vein harvesting procedure the dc extension cable casing to the cord for the hemopro (vh-3030) was damaged.Discovered prior to the case and a new cord was used.No injury to t patient as there was no patient involved.
Additional Manufacturer Narrative
Trackwise id: (b)(4).The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.
Additional Manufacturer Narrative
Trackwise # (b)(6) the device was returned to the factory for evaluation on 09/01/2022.An investigation was conducted on 09/08/2022.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.The white cord was pulled back from the green molded plug, exposing the internal wires of the cord.The other collar was observed to be intact, with no visual defects observed.No electrical testing was conducted due to the condition of the cable.Based on the returned condition of the device, and the evaluation results, the reported failure "break" was confirmed.The reported device is an oem device, therefore, a lot history review was not applicable.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.
Event or Problem Description
N/a.

• Brand Name: DC EXTENSION CABLE
• 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: 15414104
• Report Number: 2242352-2022-00778
• Device Sequence Number: 5639981
• Product Code: GEI
• UDI-Device Identifier: 00607567700888
• UDI-Public: 00607567700888
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2022

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: DC EXTENSION CABLE
• Device Catalogue Number: VH-3030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2022
• Supplement Date Received by Manufacturer: 10/06/2022
• Initial Report FDA Received Date: 09/13/2022
• Supplement Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown