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

Model Number	DC EXTENSION CABLE
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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.
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure, dc extension cable wouldn't activate.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
Additional Manufacturer Narrative
Updated sections: g4, g7, h2, h3, h6, h10.Trackwise # (b)(4).The reported device is an oem device, therefore, a lot history review was not applicable.A lot number was not provided and the specific product lot number cannot be identified from a ship history, therefore it is impossible to obtain a certificate of conformance.The device was returned to the factory for evaluation on 12nov2020.An investigation was conducted on 28dec2020.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.No visual defects were observed.An electrical evaluation was performed.The returned cable was connected to a reference power supply and a reference hemopro.A pre-cautery test was conducted per the instruction for use (ifu) to test the ability of the extension wire to deliver energy.The reference hemopro tool passed the pre-cautery test.It produced visible steam during several activations over a period of 10 minutes and shut off when the toggle was released.Based on the returned condition of the device and the results of the evaluation, the reported failure mode "failure to deliver energy" was not confirmed.
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure, dc extension cable wouldn't activate.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

• Brand Name: DC EXTENSION CABLE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 10879511
• Report Number: 2242352-2020-01040
• Device Sequence Number: 11402789
• Product Code: GEI
• UDI-Device Identifier: 00607567700888
• UDI-Public: 00607567700888
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2020

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: 11/12/2020
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 11/02/2020
• Supplement Date Received by Manufacturer: 01/04/2021
• Initial Report FDA Received Date: 11/20/2020
• Supplement Report FDA Received Date: 01/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 75