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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERILMED, INC.
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STERILMED, INC. Back to Search Results
Model Number ETH2B5LT
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/16/2014
Event Type  malfunction  
Event Description
It was reported that during a laparoscopic gyn robot case the device was leaking.The device was not replaced, but was used to complete the procedure.There was no pt injury.
 
Manufacturer Narrative
Final device investigation found that the device was returned in good visual condition.Upon eval, the stopcock lever was securely fastened and had sufficient friction to prevent unintended movement.The device was then pressure tested.The device showed no signs of leaking both with and without the obturator inserted into the sleeve.The device history record was reviewed, and no discrepancies were noted.As the device met all visual and functional testing criteria, no conclusion could be made as to what may have caused the reported event.
 
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Brand Name
NA
Manufacturer (Section D)
STERILMED, INC.
maple grove MN
Manufacturer Contact
tricia schrater
11400 73rd ave. north
maple grove, MN 55369
7634883211
MDR Report Key3950787
MDR Text Key15363103
Report Number2134070-2014-00115
Device Sequence Number1
Product Code NLM
Combination Product (y/n)N
PMA/PMN Number
K121240
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 05/16/2014
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 Expiration Date04/01/2015
Device Model NumberETH2B5LT
Device Catalogue Number2B5LT
Device Lot Number1761497
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/16/2014
Initial Date FDA Received06/09/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial
Patient Sequence Number1
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