MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC ULTIMA ACTIVATOR II REUSABLE DRIVE MECH; INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Model Number ULTIMA ACTIVATOR II REUSABLE DRIVE MECH

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Trackwise id # (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.Mdr originally submitted on october 9, 2019.Resubmitted per cdrh request from: esg help desk  on 10/10/19, at 4:47 pm, (b)(6) wrote: "hello,  we were notified that cdrh processing system had intermittent issues processing submissions ("adverse_events" and "electronic_submissions" ) from 1pm est on october 9, 2019 to 2pm est on october 10, 2019.  cdrh has requested users to resend submissions if you have not received ack3 or ack4 for your submissions sent during this time.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, ultima activator ii reusable drive mech right sided metal hook to which you attach the disposable plastic blades broke off.The hospital did not report any patient effects.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, ultima activator ii reusable drive mech right sided metal hook to which you attach the disposable plastic blades broke off.The hospital did not report any patient effects.

Manufacturer Narrative

Trackwise # (b)(4).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.

• Brand Name: ULTIMA ACTIVATOR II REUSABLE DRIVE MECH
• Type of Device: INSTRUMENTS, SURGICAL, CARDIOVASCULAR
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 9177593
• MDR Text Key: 186137765
• Report Number: 2242352-2019-01105
• Device Sequence Number: 1
• Product Code: DWS
• 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: 10/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ULTIMA ACTIVATOR II REUSABLE DRIVE MECH
• Device Catalogue Number: UA-5001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1