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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG SUCTION TUBE TAPERED TEARDROP 12FR 180MM; SUCTION CANNULAE
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AESCULAP AG SUCTION TUBE TAPERED TEARDROP 12FR 180MM; SUCTION CANNULAE Back to Search Results
Model Number GF399R
Device Problem Material Fragmentation (1261)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/20/2023
Event Type  Injury  
Event Description
It was reported to aesculap inc.On user facility medwatch report # (b)(4) that a suction tube tapered teardrop 12fr 180mm (part # gf399r) was used during an unspecified procedure on (b)(4).2023.According to the complainant, during the procedure, the device had broken.Reportedly, "all pieces were retrieved." the complaint device has not been returned to the manufacturer for evaluation.No patient complications were reported as a result of this event.The adverse event is filed under aic reference (b)(4).
 
Manufacturer Narrative
Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
 
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Brand Name
SUCTION TUBE TAPERED TEARDROP 12FR 180MM
Type of Device
SUCTION CANNULAE
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM  78501
MDR Report Key18445377
MDR Text Key331914663
Report Number2916714-2023-00128
Device Sequence Number1
Product Code GCX
UDI-Device Identifier04038653435913
UDI-Public4038653435913
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Nurse
Type of Report Initial
Report Date 01/04/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberGF399R
Device Catalogue NumberGF399R
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/04/2024
Distributor Facility Aware Date12/20/2023
Event Location Hospital
Date Report to Manufacturer12/20/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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