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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERILMED, INC.; ENDOSCOPIC TROCAR
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STERILMED, INC.; ENDOSCOPIC TROCAR Back to Search Results
Model Number APPCTS02
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
It was reported that during a laparoscopic cholecystectomy the device would not allow the surgeon to insufflate and leaked air.The device was replaced.There was no pt injury.Add'l info was requested, but no add'l info was available.
 
Manufacturer Narrative
The device was in transit to the manufacturer as of the date of this report.A supplemental report will be sent after the device is received and evaluated.
 
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Brand Name
NA
Type of Device
ENDOSCOPIC TROCAR
Manufacturer (Section D)
STERILMED, INC.
maple grove MN
Manufacturer Contact
tricia schrater
11400 73rd ave. north
maple grove, MN 55369
7634883211
MDR Report Key4174953
MDR Text Key5159823
Report Number2134070-2014-00151
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 07/16/2014
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 Date11/01/2014
Device Model NumberAPPCTS02
Device Catalogue NumberCTS02
Device Lot Number1719160
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer07/17/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/16/2014
Initial Date FDA Received08/08/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/01/2013
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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