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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ GMBH CO. KG N.A.; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED
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KARL STORZ GMBH CO. KG N.A.; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED Back to Search Results
Model Number 27074B
Device Problems Break (1069); Product Quality Problem (1506)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/06/2022
Event Type  malfunction  
Event Description
From what the doctor states, the stone was very solid/hard.This is a very uncommon procedure and the stone crushing forceps are seldom used (1-2 times a year).It looks like the pin that holds the top jaw together snapped and the jaw cleanly broke off the main instrument housing.No retained metal.An evaluation of the remaining forceps will be done by our surgical instrument company and replacements purchased for any faulty or old forceps.Manufacturer response for stone crusher, stone crusher (per site reporter).Not sure at this time.
 
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Brand Name
N.A.
Type of Device
ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED
Manufacturer (Section D)
KARL STORZ GMBH CO. KG
2151 e grand avenue
el segundo CA 90245
MDR Report Key15111916
MDR Text Key296676789
Report Number15111916
Device Sequence Number1
Product Code OCZ
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 07/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number27074B
Device Lot NumberFL01
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/18/2022
Event Location Hospital
Date Report to Manufacturer07/27/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age25185 DA
Patient SexMale
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