MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC T.W. POWER SUPPLY; UNIT, CAUTERY, THERMAL, AC-POWERED

Model Number T.W. POWER SUPPLY

Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 Description

The hospital reported that during preparation for an endoscopic vein harvesting procedure, t.W.Power supply s/n (b)(4) were working sub-optimally, and only intermittently.The hospital did not report any patient effects.

Manufacturer Narrative

Trackwise # (b)(4).Corrected section: h6- device code corrected to "intermittent continuity." the device was returned to the factory on 09/15/2020.An investigation was conducted on 10/21/2020.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.No visual defects were observed.The device was connected to a power cord and the power switch was turned to the "on" position.The device was able to be energized.The green indicator light did illuminate and the device provided energy to a reference hemopro device and extension cable.An electrical evaluation was conducted.A pre-cautery test was performed per the direction for use (dfu) with a reference cable, adapter and the returned power supply vh-3010 at level 3.0.The device passed the pre-cautery test; it produced visible steam and heat during ten (10) 3-second activations and shut off when the toggle was released.To evaluate the safety shut down system, a polyfuse activation test was performed 5 times over 10 minutes.The device shut off after the period of sustained activation and reactivated after 10-second cooling period with no incident each time.Based on the returned condition of the device, the reported failure "intermittent continuity" was not confirmed.The reported device is an oem device.The certificate of conformance was reviewed for the serial # (b)(6).The vendor certifies that this device lot conforms to all applicable product specifications and there were no non-conformances identified for the manufacturing batch.

Event Description

The hospital reported that during preparation for an endoscopic vein harvesting procedure, t.W.Power supply s/n (b)(6) were working sub-optimally and only intermittently.The hospital did not report any patient effects.

• Brand Name: T.W. POWER SUPPLY
• Type of Device: UNIT, CAUTERY, THERMAL, AC-POWERED
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 10563891
• MDR Text Key: 207927238
• Report Number: 2242352-2020-00818
• Device Sequence Number: 1
• Product Code: HQO
• UDI-Device Identifier: 00607567700826
• UDI-Public: 00607567700826
• Combination Product (y/n): N
• PMA/PMN Number: K052274
• 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: 09/21/2020

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
• Device Operator: Health Professional
• Device Model Number: T.W. POWER SUPPLY
• Device Catalogue Number: VH-3010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 09/01/2020
• Initial Date FDA Received: 09/21/2020
• Supplement Dates Manufacturer Received: 10/22/2020
• Supplement Dates FDA Received: 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1