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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CV HEMOPRO2 EXTENSION CABLE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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MAQUET CV HEMOPRO2 EXTENSION CABLE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Catalog Number C-VH-4030
Device Problems Break (1069); Crack (1135)
Patient Problem No Patient Involvement (2645)
Event Date 12/18/2018
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 preparation for an endoscopic vein harvesting procedure, hemopro2 extension cable was damaged, cord had a crack in it.A replacement device was used to complete the procedure.No patient involvement.
 
Manufacturer Narrative
Internal complaint number: (b)(4).Autonumber: (b)(4).
 
Event Description
The hospital reported that during preparation for an endoscopic vein harvesting procedure, hemopro2 extension cable was damaged, cord had a crack in it.A replacement device was used to complete the procedure.No patient involvement.
 
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Brand Name
HEMOPRO2 EXTENSION CABLE
Type of Device
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Manufacturer (Section D)
MAQUET CV
45 barbour pond drive
wayne NJ 07470
MDR Report Key8233795
MDR Text Key132812870
Report Number2242352-2019-00040
Device Sequence Number1
Product Code GEI
Combination Product (y/n)N
PMA/PMN Number
K101274
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 01/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/14/2023
Device Catalogue NumberC-VH-4030
Device Lot Number1841-1
Was Device Available for Evaluation? No
Date Manufacturer Received01/31/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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