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

Catalog Number C-UA-5001

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/13/2016

Event Type  malfunction  

Manufacturer Narrative

02/17/2016 02:23 pm (gmt-5:00) added by (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.(b)(4).

Event Description

02/12/2016 03:52 pm (gmt-5:00) added by (b)(4): the hospital reported that during a coronary artery bypass procedure, ultima activator ii reusable drive mechanical lever locked.A replacement device was used to complete the procedure.The hospital did not report any patient effects.The product is returning.02/12/2016 09:53 am (gmt-5:00) added by (b)(4) (cpl) 2 (tws): during a cabg case the surgeon went to tighten the activator lever and it was locked and couldn't be moved.The surgeon tried to loosen it and remove the ua-5100 but the lever would not move.He ended up pulling out the entire retractor and blades and replaced it with a different set up.

Manufacturer Narrative

(b)(4).This is a reusable oem device; therefore, a lot history review was not applicable.The certificate of conformance (c of c) was reviewed.The vendor certifies that this device lot conforms to all applicable product specifications.The device was returned to the factory for evaluation.Evidence of clinical use and no evidence of blood were observed.A visual inspection was conducted.No defects or marks on the activator ii drive mechanism were observed.No defects or marks were observed on the drive handle.A mechanical evaluation was conducted.The drive handle was turned to open and close the unit 5 times.No binding was observed.The handle did not lock and could rotate in clockwise and anticlockwise.Based on the results of the evaluation, the reported complaint was not confirmed.

Event Description

The hospital reported that during a coronary artery bypass procedure, ultima activator ii reusable drive mechanical lever locked.A replacement device was used to complete the procedure.The hospital did not report any patient effects.The product is returning.During a cabg case the surgeon went to tighten the activator lever and it was locked and couldn't be moved.The surgeon tried to loosen it and remove the ua-5100 but the lever would not move.He ended up pulling out the entire retractor and blades and replaced it with a different set up.

• Brand Name: ULTIMA ACTIVATOR II REUSABLE DRIVE MECH.
• Type of Device: INSTRUMENTS, SURGICAL, CARDIOVASCULAR
• Manufacturer (Section D): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer (Section G): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 5443059
• MDR Text Key: 38997334
• Report Number: 2242352-2016-00151
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/21/2016

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 Catalogue Number: C-UA-5001
• Device Lot Number: 25112656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2016
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: 01/21/2016
• Initial Date FDA Received: 02/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1