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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERILMED, INC.; LAPAROSCOPE, REPROCESSED
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STERILMED, INC.; LAPAROSCOPE, REPROCESSED Back to Search Results
Model Number APPC0R37
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/29/2014
Event Type  malfunction  
Event Description
It was reported that during a laparoscopic sleeve gastrectomy the device was leaking air while an instrument was inserted into the device.The leak appeared to be coming from the seal.Another device was used to complete the procedure.There was no patient injury.
 
Manufacturer Narrative
The device was received by the manufacturer.A supplemental report will be sent when the device investigation is completed.
 
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Brand Name
NA
Type of Device
LAPAROSCOPE, REPROCESSED
Manufacturer (Section D)
STERILMED, INC.
maple grove MN
Manufacturer Contact
tricia schrater
11400 73rd ave. north
maple grove, MN 55369
7634883211
MDR Report Key4293905
MDR Text Key20324798
Report Number2134070-2014-00193
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 10/30/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/26/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/31/2015
Device Model NumberAPPC0R37
Device Catalogue NumberC0R37
Device Lot Number1789001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/30/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/01/2014
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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