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

Model Number	DC EXTENSION CABLE
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2021
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure, dc extension cable failed to provide energy.They changed the hemopro vh3500 cord, and that fixed the issue.Based on the troubleshooting, the cord was identified as the variable.The hospital did not report any patient effects.
Additional Manufacturer Narrative
Internal complaint number: (b)(4).Trend analysis: (4110/213/67) the overall 24 month product complaint trend data for the period jun-2019 through may-2021 was reviewed.There were no triggers identified for the review period.Testing of actual/suspected device & testing of raw/starting materials: (10/4105/13/22) the device was returned to the factory on 13may2021.An investigation was conducted on 08jul2021.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 did not passed the pre-cautery test; and did not produce any visible steam.An engineering evaluation was conducted that identified the root cause of the "electrical issue".To check the wire connection in the device, the outside cable was cut open near the plug.It was evident that the defect happened when the exposed copper wire on the red and green wires came in contact with each other when the white cable was bent 90 degrees near the 3 pin molded plug which resulted in an electrical short.The lot number of this cable is unknown; as a result, its actual age and sterilization cycles cannot be determined.Based on the results of the evaluation the reported failure mode "electrical issue" was confirmed.
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
• MDR Report Key: 11900423
• Report Number: 2242352-2021-00424
• Device Sequence Number: 17056028
• Product Code: GEI
• UDI-Device Identifier: 00607567700888
• UDI-Public: 00607567700888
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 07/09/2021

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: 05/13/2021
• Initial Date Received by Manufacturer: 05/10/2021
• Supplement Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 05/28/2021
• Supplement Report FDA Received Date: 07/09/2021
• Patient Sequence Number: 1
• Patient Age: 78 YR