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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONMED CORPORATION BUFFALO FILTER IN-LINE SMOKE EVACUATION FILTER/MULTI-USE ULPA; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
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CONMED CORPORATION BUFFALO FILTER IN-LINE SMOKE EVACUATION FILTER/MULTI-USE ULPA; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED Back to Search Results
Model Number BILF200
Device Problems Product Quality Problem (1506); Wrong Label (4073)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/04/2022
Event Type  malfunction  
Event Description
The manufacturer label/sticker on the buffalo filter has been incorrectly placed on the filter and the arrow is pointing in the wrong direction, thus telling staff to hang the one-way filter upside down.Conmed is aware of this issue, there has been a response, but not what is needed.Multiple lot numbers associated: lot #s: 202206204, 202206144, 202205054, 202203034, and 202205124.
 
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Brand Name
BUFFALO FILTER IN-LINE SMOKE EVACUATION FILTER/MULTI-USE ULPA
Type of Device
APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
Manufacturer (Section D)
CONMED CORPORATION
11311 concept boulevard
largo FL 33773
MDR Report Key15672506
MDR Text Key302423065
Report Number15672506
Device Sequence Number1
Product Code GCX
UDI-Device Identifier00851136002327
UDI-Public00851136002327
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberBILF200
Device Catalogue NumberBILF200
Device Lot Number202206204
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/20/2022
Event Location Hospital
Date Report to Manufacturer10/26/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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