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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 APPCTR73
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/17/2014
Event Type  malfunction  
Event Description
It was reported that during a lower anterior laparoscopic procedure two devices were leaking gas.The devices were replaced.There was no pt injury.
 
Manufacturer Narrative
Final device investigation found that only the component that attaches to the proximal end of the sleeve was returned.The remainder of the sleeve and the obturator were not returned.Upon eval it was found that there was a crack on the stopcock.No pressure testing could be performed.The lot number was not provided so the device history record could not be reviewed.
 
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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 Key3879827
MDR Text Key4590510
Report Number2134070-2014-00032
Device Sequence Number1
Product Code NLM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/20/2014
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 Model NumberAPPCTR73
Device Catalogue NumberCTR73
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer02/01/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/20/2014
Initial Date FDA Received02/11/2014
Was Device Evaluated by Manufacturer? Yes
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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