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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO STANDARD CABLE; UNIT, OPERATIVE DENTAL
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STRYKER INSTRUMENTS-KALAMAZOO STANDARD CABLE; UNIT, OPERATIVE DENTAL Back to Search Results
Model Number 5100004000
Device Problem Unintended Power Up (1162)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/04/2020
Event Type  malfunction  
Event Description
The user facility reported that the device had unintended activation during testing prior to a procedure.  there was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
Manufacturer Narrative
Corrected data: h6.This event was originally reported under stryker vmsr report 0001811755-2021-00154 on (b)(6) 2021 with the device code of 'device remains activated'.Upon completion of the investigation for the device, stryker corrected the device code to 'unintended power up' and replaced the previous vmsr report with this corrected mdr.
 
Event Description
The user facility reported that the device had unintended activation during testing prior to a procedure.  there was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
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Brand Name
STANDARD CABLE
Type of Device
UNIT, OPERATIVE DENTAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key11731477
MDR Text Key252358156
Report Number3015967359-2021-00527
Device Sequence Number1
Product Code EIA
UDI-Device Identifier04546540970275
UDI-Public04546540970275
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 05/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number5100004000
Device Catalogue Number5100004000
Device Lot Number20210
Was Device Available for Evaluation? Yes
Date Manufacturer Received05/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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