Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERILMED, INC.
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STERILMED, INC. Back to Search Results
Device Problem Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/12/2013
Event Type  malfunction  
Event Description
It was reported that during a laparoscopic cholecystectomy when they were getting ready for the cholangiogram, it was noticed that there was a black piece of rubber on the liver.The piece was fished out.It was not known from which of 3 devices the piece came.They were far enough in the procedure that the devices were not exchanged.There was no patient injury.
 
Manufacturer Narrative
The device was either model and lot number appctr03 (lot #1680587) or appcts02 (lot #1689329) with an expiration date of 08/01/2014 or 10/01/2014, respectively.The device was not returned to the mfr as of the date of this report and was reported to be discarded by the user facility.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key3647197
MDR Text Key4201229
Report Number2134070-2014-00003
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 12/16/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/16/2013
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Age25 YR
-
-