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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO EZOUT ATTACHMENT; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

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STRYKER INSTRUMENTS-KALAMAZOO EZOUT ATTACHMENT; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Catalog Number 7202100000
Device Problem Leak/Splash (1354)
Patient Problem Skin Discoloration (2074)
Event Date 05/24/2017
Event Type  malfunction  
Event Description
It was reported that during a surgical procedure at the user facility the ezout attachment discolored along with the tissue and skin of the patient.The procedure was completed successfully without a clinically significant delay; no medical intervention was reported.
 
Manufacturer Narrative
Device not returned to manufacturer for evaluation.
 
Event Description
It was reported that during a surgical procedure at the user facility the ezout attachment discolored along with the tissue and skin of the patient.The procedure was completed successfully without a clinically significant delay; no medical intervention was reported.
 
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Brand Name
EZOUT ATTACHMENT
Type of Device
INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key6665094
MDR Text Key78357600
Report Number0001811755-2017-01338
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 09/29/2017
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 Catalogue Number7202100000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/29/2017
Initial Date FDA Received06/23/2017
Supplement Dates Manufacturer Received09/28/2017
Supplement Dates FDA Received09/29/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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