Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CV ULTIMA ACTIVATOR II REUSABLE DRIVE MECH.; INSTRUMENTS, SURGICAL, CARDIOVASCULAR
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MAQUET CV ULTIMA ACTIVATOR II REUSABLE DRIVE MECH.; INSTRUMENTS, SURGICAL, CARDIOVASCULAR Back to Search Results
Catalog Number C-UA-5001
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/14/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).A lot history record review was completed for the reported product lot number.There were no ncmr¿s for the reported lot number.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.
 
Event Description
The hospital reported that during a coronary artery bypass procedure, ultima activator ii reusable drive mech.Retractor arm had gapping at the joints.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
Event Description
The hospital reported that during a coronary artery bypass procedure, ultima activator ii reusable drive mech.Retractor arm had gapping at the joints.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
Manufacturer Narrative
(b)(4).The device was returned to the factory for evaluation.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.There were no visual defects observed on the driving mechanism.No evidence of beading or visual defects were observed on the teeth of the device, or the retractor arm having gapping at the joints.A mechanical evaluation was conducted.The crank lever was rotated both clockwise and counter-clockwise to determine the fluidity of the device's movement.There was no resistance felt.The device was attached to two reference acrobat blades.Once the blades were attached, the lever was once again rotated and the device retracted with no resistance felt.Based on the returned condition of the device, and the results of the evaluation, the reported failure "mechanical issue" is not confirmed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
MDR Report Key8148016
MDR Text Key130180107
Report Number2242352-2018-01271
Device Sequence Number1
Product Code DWS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/10/2018
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 NumberC-UA-5001
Device Lot Number25081546
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/03/2019
Initial Date Manufacturer Received 11/14/2018
Initial Date FDA Received12/10/2018
Supplement Dates Manufacturer Received04/09/2019
Supplement Dates FDA Received04/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-