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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO EYE STRETCHER CHAIR; STRETCHER, WHEELED
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STRYKER MEDICAL-KALAMAZOO EYE STRETCHER CHAIR; STRETCHER, WHEELED Back to Search Results
Catalog Number 5051000000
Device Problems Unintended Head Motion (1284); Improper or Incorrect Procedure or Method (2017); Unintended Movement (3026)
Patient Problem Capsular Bag Tear (2639)
Event Date 06/01/2018
Event Type  Injury  
Event Description
It was reported that during cataract surgery the surgeon went to rest his foot on the side of their 5051 stretcher and hit the trendelenberg pedal by mistake, which caused the stretcher to drop fast, resulting in the surgeon to breaking the capsule in the patient's eye.It was reported approximately 10 minutes were added to the procedure time, but the surgery was completed successfully.The facility stated there was no known permanent impairment to the patient as a result.
 
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Brand Name
EYE STRETCHER CHAIR
Type of Device
STRETCHER, WHEELED
Manufacturer (Section D)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
Manufacturer (Section G)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
Manufacturer Contact
kristen canter
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key7639556
MDR Text Key112417338
Report Number0001831750-2018-00614
Device Sequence Number1
Product Code FPO
UDI-Device Identifier07613327278361
UDI-Public07613327278361
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial
Report Date 06/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Catalogue Number5051000000
Was Device Available for Evaluation? Yes
Date Manufacturer Received06/01/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/22/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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