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

Model Number	DC EXTENSION CABLE
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure using dc extension cable.They observed the vh-3500 jaws activating when only half closed.They removed the device from the table and opened a new kit.The same extension cable was used without an issue.
Additional Manufacturer Narrative
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 for evaluation on (b)(6) 2021.An investigation was conducted on (b)(6) 2021.A visual inspection was conducted.Signs of clinical use and slight evidence of blood was observed on the cable.Both the connector and pigtail connection was observed to be intact, no visual defects were observed.An electrical evaluation was performed.To test the ability of the extension wire to deliver energy, a pre-cautery test was conducted per the instruction for use (ifu).A reference device was also used.The cable was also attached to a hemopro tool, it passed the pre-cautery test; it produced visible steam during several activations over a period of 10 minutes.No specific failure was alleged for the reported device, and we are unable to confirm any failures.
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure using dc extension cable.They observed the vh-3500 jaws activating when only half closed.They removed the device from the table and opened a new kit.The same extension cable was used without an issue.

• 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: 11109328
• Report Number: 2242352-2021-00018
• Device Sequence Number: 1115255
• Product Code: GEI
• UDI-Device Identifier: 00607567700888
• UDI-Public: 00607567700888
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 12/30/2020

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: 01/05/2021
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 12/10/2020
• Supplement Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 01/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 120