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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CV HEMOPRO2 ADAPTOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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MAQUET CV HEMOPRO2 ADAPTOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Catalog Number C-VH-4020
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Patient Involvement (2645)
Event Date 01/10/2019
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 preparation for an endoscopic vein harvesting procedure using hemopro2 adaptor.Upon connecting the extension cord to the adapter the connection dislodged.A replacement device was used to complete the procedure.No patient involvement.
 
Manufacturer Narrative
The device was discarded.(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.
 
Event Description
The hospital reported that during preparation for an endoscopic vein harvesting procedure using hemopro2 adaptor.Upon connecting the extension cord to the adapter the connection dislodged.A replacement device was used to complete the procedure.No patient involvement.
 
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Brand Name
HEMOPRO2 ADAPTOR
Type of Device
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Manufacturer (Section D)
MAQUET CV
45 barbour pond drive
wayne NJ 07470
MDR Report Key8308494
MDR Text Key135189399
Report Number2242352-2019-00146
Device Sequence Number1
Product Code GEI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 02/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberC-VH-4020
Was Device Available for Evaluation? No
Date Manufacturer Received03/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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