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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERILMED, INC.; CLIP, IMPLANTABLE, REPROCESSED
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STERILMED, INC.; CLIP, IMPLANTABLE, REPROCESSED Back to Search Results
Model Number ETHER320
Device Problems Failure to Fold (1255); Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/22/2014
Event Type  malfunction  
Event Description
It was reported that during a laparoscopic cholecystectomy the clip failed to remain closed after.Firing.The clip would not close completely and was partially closed.Some clips were successfully fired prior to the event, but the number was unk.The device was not fired over other clips.The issue was noticed immediately, and the device was replaced.There was no pt injury.
 
Manufacturer Narrative
The device was returned to the mfr and will undergo device eval.A supplemental report will be sent when the eval is complete.
 
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Brand Name
NA
Type of Device
CLIP, IMPLANTABLE, REPROCESSED
Manufacturer (Section D)
STERILMED, INC.
maple grove MN
Manufacturer Contact
tricia schrater
11400 73rd ave. north
maple grove, MN 55369
7634883211
MDR Report Key4262124
MDR Text Key5007346
Report Number2134070-2014-00187
Device Sequence Number1
Product Code NMJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K033579
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 10/09/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2014
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 NumberETHER320
Device Catalogue NumberER320
Device Lot Number1786060
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer10/24/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/09/2014
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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