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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CV ULTIMA ACTIVATOR II REUSABLE DRIVE MECH.; INSTRUMENTS, SURGICAL, CARDIOVASCULAR
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MAQUET CV ULTIMA ACTIVATOR II REUSABLE DRIVE MECH.; INSTRUMENTS, SURGICAL, CARDIOVASCULAR Back to Search Results
Catalog Number C-UA-5001
Device Problem Sticking (1597)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/30/2015
Event Type  malfunction  
Manufacturer Narrative
(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.
 
Event Description
The hospital reported that during a coronary artery bypass procedure, the ultima activator ii reusable drive mechanical hand crank would barely move to open the retractor.It was not matched to correct specifications.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.No signs of blood or clinical use 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.We were unable to replicate the reported failure.Based on the results of the evaluation, the reported complaint was unable to be confirmed.
 
Event Description
The hospital reported that during a coronary artery bypass procedure, the ultima activator ii reusable drive mechanical hand crank would barely move to open the retractor.It was not matched to correct specifications.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
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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 Key5173997
MDR Text Key29818468
Report Number2242352-2015-01196
Device Sequence Number1
Product Code DWS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 09/30/2015
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
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/09/2015
Is the Reporter a Health Professional? Yes
Device AgeYR
Initial Date Manufacturer Received 09/30/2015
Initial Date FDA Received10/24/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received02/04/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age78 YR
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