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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PARAGON 28, INC JAWS NITINOL STAPLE SYSTEM; STRAIGHT STAPLE ASSEMBLY, 8 X 8MM
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PARAGON 28, INC JAWS NITINOL STAPLE SYSTEM; STRAIGHT STAPLE ASSEMBLY, 8 X 8MM Back to Search Results
Model Number P71-008-0808-S
Device Problems Mechanical Problem (1384); Use of Device Problem (1670); Firing Problem (4011)
Patient Problem Insufficient Information (4580)
Event Date 04/26/2021
Event Type  malfunction  
Manufacturer Narrative
Device disposed of and not expected to be returned to the manufacturer.If further information is identified which would change or alter information or conclusions a supplemental report will be filed accordingly.
 
Event Description
Surgeon wasn't able us the drill guide to drill the staple hole as the barrel holes were filled in/plugged with a plastic material, so he free-handed the drilling for the staple.
 
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Brand Name
JAWS NITINOL STAPLE SYSTEM
Type of Device
STRAIGHT STAPLE ASSEMBLY, 8 X 8MM
Manufacturer (Section D)
PARAGON 28, INC
14445 grasslands dr
englewood CO 80112
Manufacturer Contact
jenny conger
14445 grasslands dr
englewood, CO 80112
MDR Report Key11862848
MDR Text Key255095798
Report Number3008650117-2021-00093
Device Sequence Number1
Product Code JDR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170923
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberP71-008-0808-S
Device Catalogue NumberP71-008-0808-S
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/26/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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