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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
Device Problem Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/17/2018
Event Type  malfunction  
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 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
Type of Device
HEYMAN NASAL SCISSORS
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
78532
tuttlingen,
GM 
MDR Report Key8259125
MDR Text Key133487775
Report Number9610617-2019-00002
Device Sequence Number1
Product Code LRC
UDI-Device Identifier04048551392720
UDI-Public4048551392720
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 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
Device Operator 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 Manufacturer Received 01/07/2019
Initial Date FDA Received01/17/2019
Supplement Dates Manufacturer Received01/07/2019
Supplement Dates FDA Received01/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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