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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO NSE FOOTSWITCH; DRIVER, WIRE, AND BONE DRILL, MANUAL
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STRYKER INSTRUMENTS-KALAMAZOO NSE FOOTSWITCH; DRIVER, WIRE, AND BONE DRILL, MANUAL Back to Search Results
Catalog Number 5400007000
Device Problem Unintended Power Up (1162)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/14/2020
Event Type  malfunction  
Manufacturer Narrative
Device not returned.
 
Event Description
The customer reported that the drill turned on during the case without anyone pressing the foot pedal.The issue persisted when equipment other than the pedal was changed.No further information has been reported at this time.
 
Event Description
The customer reported that the drill turned on during the case without anyone pressing the foot pedal.The issue persisted when equipment other than the pedal was changed.No further information has been reported at this time.
 
Manufacturer Narrative
Additional information: d1, d2, d3, d4 (device identifying information), d9 (product availability).Corrected data: h6 codes.
 
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Brand Name
NSE FOOTSWITCH
Type of Device
DRIVER, WIRE, AND BONE DRILL, MANUAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key10613878
MDR Text Key209400764
Report Number0001811755-2020-02539
Device Sequence Number1
Product Code DZJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 12/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number5400007000
Was Device Available for Evaluation? Yes
Date Manufacturer Received12/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
5407100000, SN UNKNOWN; 5407100000, SN UNKNOWN
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