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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA BARD-PARKER CARBON RIB-BACK BLADES SIZE 11, STERILE

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ASPEN SURGICAL PRODUCTS, CALEDONIA BARD-PARKER CARBON RIB-BACK BLADES SIZE 11, STERILE Back to Search Results
Model Number 371111
Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/14/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
We were notified of a complaint from a customer stating on (b)(6) during a knee operation a blade fell off the handle and into the cavity of the patient. The surgeon made several attempts to remove the blade with different surgical instruments, and was finally successful in removing the blade by using a hemostat. There was no injury to the patient and no medical intervention was required. After the blade was removed, the surgical tech attempted to place the blade back on the handle and at that time the blade broke. A medwatch has been filed for this incident and the reference number is (b)(4).
 
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Brand NameBARD-PARKER CARBON RIB-BACK BLADES SIZE 11, STERILE
Type of DeviceBARD-PARKER CARBON RIB-BACK BLADES SIZE 11
Manufacturer (Section D)
ASPEN SURGICAL PRODUCTS, CALEDONIA
6945 southbelt dr. s.e.
caledonia MI 49316
Manufacturer Contact
bradley liske
6945 southbelt dr. s.e.
caledonia, MI 49316
MDR Report Key6256190
MDR Text Key65465692
Report Number1836161-2017-00004
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 12/20/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/17/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number371111
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/20/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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