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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HEYMAN NASAL SCISSORS
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KARL STORZ SE & CO. KG HEYMAN NASAL SCISSORS Back to Search Results
Model Number 449002
Medical Device Problem Code Material Separation (1562)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 12/17/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The broken instrument was returned for evaluation.We confirmed that one side of the scissors jaw is broken off and was not returned by the facility.The remaining jaw has dents on the edge.The instrument had been in use for almost five years.Damage is most likely due to excessive force and/or handling of the device.
 
Event or Problem Description
Allegedly, during a septoplasty procedure, one of the jaws broke off inside the patient.The piece was retrieved and there was not harm to the patient.
 
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Brand Name
HEYMAN NASAL SCISSORS
Common Device Name
HEYMAN NASAL SCISSORS
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
78532
tuttlingen,
GM 
MDR Report Key8259125
Report Number9610617-2019-00002
Device Sequence Number16178323
Product Code LRC
UDI-Device Identifier04048551392720
UDI-Public4048551392720
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,user f
Initial Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date (Section B) 12/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number449002
Device Catalogue Number449002
Device Lot NumberTX01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/07/2019
Initial Date Received by Manufacturer 01/07/2019
Supplement Date Received by Manufacturer01/07/2019
Initial Report FDA Received Date01/17/2019
Supplement Report FDA Received Date01/18/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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