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.; ENDOSCOPIC TROCAR
  • 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.; ENDOSCOPIC TROCAR Back to Search Results
Model Number ETHB12LT
Device Problems Break (1069); Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/10/2014
Event Type  malfunction  
Event Description
It was reported that during a laparoscopic cholecystectomy the gasket ring disconnected from the trocar sleeve in the middle of the procedure resulting in a loss of pneumoperitoneum.Pneumo could not be maintained.Nothing broke off in the pt.A new device had to be inserted.There was no pt injury.
 
Manufacturer Narrative
The device was returned to the manufacturer and is undergoing eval.A supplemental report will be sent when device eval is complete.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key4174978
MDR Text Key5100072
Report Number2134070-2014-00148
Device Sequence Number1
Product Code NLM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K052299
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 07/11/2014
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 Date05/01/2015
Device Model NumberETHB12LT
Device Catalogue NumberB12LT
Device Lot Number1774257
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer08/01/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/11/2014
Initial Date FDA Received08/08/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-