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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 15 BLADE

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ASPEN SURGICAL BARD PARKER BLADE SURG RIB BCK CARB 15 BLADE Back to Search Results
Model Number 371115
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/04/2022
Event Type  malfunction  
Event Description
The 15 blade snapped in half when removing from handle. There was patient contact, but the blade snapped once the procedure was finished. There was no harm to patient.
 
Manufacturer Narrative
The 15 blade is a component contained within roi cps, llc convenience kit 880118, lot 90086.
 
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Brand NameBARD PARKER
Type of DeviceBLADE SURG RIB BCK CARB 15 BLADE
Manufacturer (Section D)
ASPEN SURGICAL
6945 southbelt dr. s.e.
caledonia MI 49316
Manufacturer (Section G)
ROI CPS, LLC
3000 east sawyer road
republic MO 65738
Manufacturer Contact
cheyenne stewart
3000 east sawyer road
republic, MO 65738
4176473205
MDR Report Key13334456
MDR Text Key294402912
Report Number3014527682-2022-00001
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,User Facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 01/24/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/24/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number371115
Device Catalogue Number371115
Device Lot Number260152
Was Device Available for Evaluation? No
Date Manufacturer Received01/04/2022
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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