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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SMARTPUMP DUAL CHANNEL; TOURNIQUET, PNEUMATIC
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STRYKER INSTRUMENTS-KALAMAZOO SMARTPUMP DUAL CHANNEL; TOURNIQUET, PNEUMATIC Back to Search Results
Catalog Number 5920011000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Blood Loss (2597)
Event Date 02/10/2015
Event Type  Injury  
Event Description
During a surgical procedure at the user facility on the right index finger to repair the tendon, debride skin/subcutaneous tissue and repair the radial digital nerve, the customer experienced difficulty adjusting the tourniquet cuff, which was slipping, regardless of the snug fitting.After engaging the tourniquet pump, the surgeon noticed bleeding.Bleeding continued to increase, making visualization difficult, with an estimated blood loss of 30cc.The procedure was completed successfully using back-up equipment.Switching to back-up equipment resulted in a prolongation to the procedure of unknown length.No further information regarding this event is available from the user facility.
 
Manufacturer Narrative
Device not returned.
 
Manufacturer Narrative
This correction is being filed to update outcomes attributed to the adverse event.
 
Event Description
During a surgical procedure at the user facility on the right index finger to repair the tendon, debride skin/subcutaneous tissue and repair the radial digital nerve, the customer experienced difficulty adjusting the tourniquet cuff, which was slipping, regardless of the snug fitting.After engaging the tourniquet pump, the surgeon noticed bleeding.Bleeding continued to increase, making visualization difficult, with an estimated blood loss of 30cc.The procedure was completed successfully using back-up equipment.Switching to back-up equipment resulted in a prolongation to the procedure of unknown length.No further information regarding this event is available from the user facility.
 
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Brand Name
SMARTPUMP DUAL CHANNEL
Type of Device
TOURNIQUET, PNEUMATIC
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key4874734
MDR Text Key18386805
Report Number0001811755-2015-02340
Device Sequence Number1
Product Code KCY
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,user facility
Type of Report Initial,Followup
Report Date 11/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number5920011000
Was Device Available for Evaluation? No
Date Manufacturer Received11/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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