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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 APPC0R37
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/16/2013
Event Type  malfunction  
Event Description
It was reported that during a gastric sleeve procedure the seal on the device was not sealing.Another device 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 evaluation, the device was pressure tested and showed signs of leaking when the obturator was inserted into the device, but not when the sleeve was tested alone.The lot number of the device 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 Key3698237
MDR Text Key4246010
Report Number2134070-2014-00014
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 Nurse
Type of Report Initial
Report Date 12/19/2013
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 NumberAPPC0R37
Device Catalogue NumberC0R37
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer01/02/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/19/2013
Initial Date FDA Received01/10/2014
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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