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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY GROSS TRACTION ASSEMBLY TO OT1100 SURGICAL TABLE
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STERIS CORPORATION - MONTGOMERY GROSS TRACTION ASSEMBLY TO OT1100 SURGICAL TABLE Back to Search Results
Device Problem Device Slipped (1584)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/17/2021
Event Type  malfunction  
Manufacturer Narrative
A steris service technician arrived onsite to inspect the gross traction assembly and was able to duplicate the reported event.The gross traction assembly will be returned for evaluation.A follow-up mdr will be submitted when additional information becomes available.
 
Event Description
The user facility reported that during a patient procedure their ot1100 surgical table gross traction assembly was unlocking.User facility personnel had to move the patient to a new table to complete the procedure resulting in a procedure delay.No report of injury.
 
Manufacturer Narrative
The unit subject of the event was returned to steris for evaluation and it was determined that the teeth rack within the unit was misaligned.The evaluation could not determine how the teeth rack became misaligned.The user facility was provided with a replacement gross traction assembly.No additional issues have been reported.
 
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Brand Name
GROSS TRACTION ASSEMBLY TO OT1100 SURGICAL TABLE
Type of Device
GROSS TRACTION ASSEMBLY
Manufacturer (Section D)
STERIS CORPORATION - MONTGOMERY
2720 gunter park drive east
montgomery AL 36109
MDR Report Key11970394
MDR Text Key260132848
Report Number1043572-2021-00040
Device Sequence Number1
Product Code JEA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 06/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
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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