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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CV ACROBAT-I STABILIZER; STABILIZER,HEART
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MAQUET CV ACROBAT-I STABILIZER; STABILIZER,HEART Back to Search Results
Catalog Number C-OM-10000
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/28/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).A lot history record review was completed for the reported product lot number.There was no nonconformance recorded in the lot history.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 preparation for an endoscopic vein harvesting procedure, acrobat-i stabilizer when removing the device and before it was used, the sluggishness of the horizontal joint was criticized.The joint could only be mobilized by higher force.Described problem occurred several times with different devices.Stabilizer has been replaced by a new device and the procedure has been performed without any problems.
 
Manufacturer Narrative
(b)(4).The device was returned to the factory for evaluation.Signs of clinical use without evidence of blood were observed.A visual inspection was performed.No visual defects were observed.The device was evaluated for its mechanical function.The device was securely assembled onto a reference retractor blade by sliding the stabilizer base onto the rail and locking the lever.The knob was evaluated for its ability to tighten the flexlink arm while the locking lever was in both the locked and unlocked positions.The flexlink arm was secured in position when the knob was turned clockwise.The knob did tighten the arm.The knob was then turned counter-clockwise.The flexlink arm loosened and became movable on its swivel up to 180 degrees without difficulty and using moderate force only.It was also observed that the malleable stabilizer foot is able to rotate with no difficulty.Based on the returned condition of the device, the photographs provided by the complainant, and the results of the evaluation, the reported failure mode "mechanical issue" was not confirmed.
 
Event Description
The hospital reported that during preparation for an endoscopic vein harvesting procedure, acrobat-i stabilizer when removing the device and before it was used, the sluggishness of the horizontal joint was criticized.The joint could only be mobilized by higher force.Described problem occurred several times with different devices.Stabilizer has been replaced by a new device and the procedure has been performed without any problems.
 
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Brand Name
ACROBAT-I STABILIZER
Type of Device
STABILIZER,HEART
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 Key7295713
MDR Text Key101132498
Report Number2242352-2018-00182
Device Sequence Number1
Product Code MWS
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2019
Device Catalogue NumberC-OM-10000
Device Lot Number25133871
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/12/2018
Is the Reporter a Health Professional? No
Device AgeYR
Date Manufacturer Received04/04/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/28/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age65 YR
Patient Weight76
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