• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL BARD-PARKER BLADE SURG RIB BCK CARB 10

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ASPEN SURGICAL BARD-PARKER BLADE SURG RIB BCK CARB 10 Back to Search Results
Model Number 371110
Device Problem Dull, Blunt (2407)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/15/2020
Event Type  malfunction  
Event Description
Event discovered during procedure and involved patient contact. 10 blades in at least 3 main or packs are dull. The dull blades were contained within roi cps, llc custom procedure pack 880011, lot 78068.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBARD-PARKER
Type of DeviceBLADE SURG RIB BCK CARB 10
Manufacturer (Section D)
ASPEN SURGICAL
6945 southbelt dr.
caledonia, mi
Manufacturer (Section G)
ROI CPS, LLC
3000 east sawyer road
republic, mo
Manufacturer Contact
cheyenne stewart
3000 east sawyer road
republic, mo 
7303937
MDR Report Key10260731
MDR Text Key200048358
Report Number3014527682-2020-00008
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 user facility
Reporter Occupation Non-Healthcare Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 07/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number371110
Device Lot Number0209336
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/17/2020
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

-
-