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U.S. Department of Health and Human Services

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

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ASPEN SURGICAL BARD-PARKER BLADE SURG RIB BCK BARB 10 Back to Search Results
Model Number 371110
Device Problem Dull, Blunt (2407)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/29/2020
Event Type  malfunction  
Manufacturer Narrative
Roi cps, llc has reported a this event to the blade manufacturer (aspen surgical). Roi cps, llc received a complaint closure letter from aspen surgical in response to a complaint filed in june 2020 which outlines that the blade manufacturer opened a capa to address the dull blades. I have attached the complaint response letter to this record. To date, the complaints received by roi cps, llc have been for the same manufacturer item number and lot number that is outlined in the response letter.
 
Event Description
10 blade in packs were dull. 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 number 79925ag.
 
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Brand NameBARD-PARKER
Type of DeviceBLADE SURG RIB BCK BARB 10
Manufacturer (Section D)
ASPEN SURGICAL
6945 southbelt dr
caledonia, mi
Manufacturer (Section G)
ASPEN SURGICAL
6945 southbelt dr
caledonia, mi
Manufacturer Contact
cheyenne stewart
3000 east sawyer road
republic, mo 
7303937
MDR Report Key10622922
MDR Text Key229816158
Report Number3014527682-2020-00016
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 10/02/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/02/2020
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/30/2020
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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