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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CV BOM 7MM EXTENDED LENGTH ENDOSCOPE LAPAROSCOPE, GENERAL & PLASTIC SURGERY

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MAQUET CV BOM 7MM EXTENDED LENGTH ENDOSCOPE LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Catalog Number C-VH-1111
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 04/12/2018
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 sterilization/sanitation preparation for an endoscopic vein harvesting procedure, bom 7mm extended length endoscope was blurry. It was swapped out; cleaned and reissued and the same problem occurred. No patient involvement.

 
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Brand NameBOM 7MM EXTENDED LENGTH ENDOSCOPE
Type of DeviceLAPAROSCOPE, GENERAL & PLASTIC SURGERY
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 Key7488715
MDR Text Key107589444
Report Number2242352-2018-00423
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK014250
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial,Followup
Report Date 05/04/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/04/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberC-VH-1111
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/09/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/14/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured02/27/2017
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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