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

Model Number	DC EXTENSION CABLE
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.Device discarded.
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure using dc extension cable, customer says vh-3030 seemed damaged during sterilization by spd.The end of cord would not plug into vh-3500.New cord opened to finish the case.No pt was harmed.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Internal complaint number: (b)(4).Trend analysis: ((b)(4)).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.

• 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: 11947404
• Report Number: 2242352-2021-00443
• Device Sequence Number: 1061003
• Product Code: GEI
• UDI-Device Identifier: 00607567700888
• UDI-Public: 00607567700888
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 06/25/2021

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?: No
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 06/07/2021
• Supplement Report FDA Received Date: 06/29/2021
• Patient Sequence Number: 1