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

Model Number DC EXTENSION CABLE

Device Problems Intermittent Continuity (1121); Electrical /Electronic Property Problem (1198)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/08/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.Device not returned.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, dc extension cable didn't seal correctly.They switched out the vh3030 cord and it seems to work correctly for a while.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, dc extension cable didn't seal correctly.They switched out the vh3030 cord and it seems to work correctly for a while.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

Correct section: h-6: device codes: correct from "electrical issue" to "intermittent continuity".Internal complaint number: (b)(4).This is a reusable oem device; therefore, a lot /serial history review was not applicable.A serial/lot number was not provided and the specific product serial/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.An investigation was conducted on 11/15/2019.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.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).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.The cable was evaluated for electrical continuity using a multimeter.The connection between plug 1 - din 3, plug 2 - din 1 and plug 3 - din 5 were evaluated.Continuity was confirmed at all the connections.Based on the results of the evaluation the reported failure mode "intermittent continuity" was not confirmed.

• Brand Name: DC EXTENSION CABLE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 8838912
• MDR Text Key: 152628032
• Report Number: 2242352-2019-00867
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DC EXTENSION CABLE
• Device Catalogue Number: VH-3030
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 65