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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC 7MM EXTENDED LENGTH ENDOSCOPE; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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MAQUET CARDIOVASCULAR LLC 7MM EXTENDED LENGTH ENDOSCOPE; LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number 7MM EXTENDED LENGTH ENDOSCOPE
Device Problem Connection Problem (2900)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Trackwise id# (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 a concern about 7mm extended length endoscope used for endoscopic vein harvesting procedures.They are refurbished by a 3rd party.There is a concern the connection at the head of the endoscope and the stryker camera may have issues.No patient involvement.
 
Manufacturer Narrative
Trackwise # (b)(4).The reported device is an oem device, therefore, a lot history review was not applicable.The product is not returning.A lot/serial number was not provided and the specific product lot/serial number cannot be identified from a ship history, therefore it is impossible to obtain a certificate of conformance.
 
Event Description
The hospital reported a concern about 7mm extended length endoscope used for endoscopic vein harvesting procedures.They are refurbished by a 3rd party.There is a concern the connection at the head of the endoscope and the stryker camera may have issues.No patient involvement.
 
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Brand Name
7MM EXTENDED LENGTH ENDOSCOPE
Type of Device
LAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
MAQUET CARDIOVASCULAR LLC
45 barbour pond drive
wayne NJ 07470
MDR Report Key11356021
MDR Text Key232858317
Report Number2242352-2021-00145
Device Sequence Number1
Product Code GCJ
UDI-Device Identifier00607567700802
UDI-Public00607567700802
Combination Product (y/n)N
PMA/PMN Number
K014250
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 02/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number7MM EXTENDED LENGTH ENDOSCOPE
Device Catalogue NumberVH-1111
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Manufacturer Received04/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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