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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL BARD-PARKER BLADE SURG RIB BCK CARB 11

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ASPEN SURGICAL BARD-PARKER BLADE SURG RIB BCK CARB 11 Back to Search Results
Model Number 371111
Device Problems Break (1069); Dull, Blunt (2407)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/07/2020
Event Type  malfunction  
Event Description
11 blade snapped in half during case. Discovered during case. There was patient contact; however, no harm to patient and no delay to case. The dull blades were contained within roi cps, llc custom pack 880096033-nuero pack lot 79925ag.
 
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Brand NameBARD-PARKER
Type of DeviceBLADE SURG RIB BCK CARB 11
Manufacturer (Section D)
ASPEN SURGICAL
6945 southbelt dr
caledonia MI 49316
Manufacturer (Section G)
ASPEN SURGICAL
6945 southbelt dr
caledonia MI 49316
Manufacturer Contact
cheyenne stewart
3000 east sawyer road
republic, MO 65738
4177303937
MDR Report Key10658785
MDR Text Key212794138
Report Number3014527682-2020-00018
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 health professional
Reporter Occupation
Type of Report Initial
Report Date 10/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number371111
Device Lot Number0202069, 0212476
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/07/2020
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 Initial

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