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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PERFUSION SYSTEMS PITUITARY CLAMP CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY

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MEDTRONIC PERFUSION SYSTEMS PITUITARY CLAMP CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY Back to Search Results
Catalog Number UNKNOWN
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/22/2016
Event Type  malfunction  
Event Description
Pituitary clamp broke during microdiscectomy surgery. No untoward effect to patient. Device was taken out of service.
 
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Brand NamePITUITARY CLAMP
Type of DeviceCLAMP, SURGICAL, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
MEDTRONIC PERFUSION SYSTEMS
7611 northland dr.
minneapolis MN 55428
MDR Report Key6173693
MDR Text Key62363749
Report Number6173693
Device Sequence Number0
Product Code HAE
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 10/18/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/14/2016
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/18/2016
Event Location Hospital
Date Report to Manufacturer10/18/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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