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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CAST CUTTER 230 V SAW, POWERED, AND ACCESSORIES
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STRYKER INSTRUMENTS-KALAMAZOO CAST CUTTER 230 V SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 0941000000
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Laceration(s) (1946)
Event Date 12/20/2017
Event Type  Injury  
Event Description

It was reported at the user facility that the device cut a patient during a procedure. Attempts are being made to obtain additional information about the event; no further information has been received at this time.

 
Manufacturer Narrative

Device not returned for evaluation.

 
Event Description

It was reported at the user facility that the device cut a patient during a procedure. Attempts are being made to obtain additional information about the event; no further information has been received at this time.

 
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Brand NameCAST CUTTER 230 V
Type of DeviceSAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer Contact
zach baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key7201225
MDR Text Key97580047
Report Number0001811755-2018-00060
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeGB
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/28/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/17/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number0941000000
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/20/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/23/2008
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 01/17/2018 Patient Sequence Number: 1
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