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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERILMED, INC.; LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED
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STERILMED, INC.; LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED Back to Search Results
Model Number ETHH12LP
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/19/2017
Event Type  malfunction  
Manufacturer Narrative
The device has not yet been returned to the manufacturer at the time of this report.A supplemental form will be sent once the evaluation is completed if the device is returned.The device history report was not reviewed as no lot number was given.(b)(6).(b)(4).
 
Event Description
It was reported that a black circular part broke off of the device during the procedure.Additional information has been requested but additional information was not received.
 
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Brand Name
NA
Type of Device
LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED
Manufacturer (Section D)
STERILMED, INC.
11400 73rd ave.
maple grove MN 55369
Manufacturer Contact
jay anderson
5010 cheshire parkway
ste 2
plymouth, MN 55446
MDR Report Key6657166
MDR Text Key78085228
Report Number2134070-2017-00053
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 company representative,health
Reporter Occupation Health Professional
Type of Report Initial
Report Date 05/23/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberETHH12LP
Device Catalogue NumberETHH12LP
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/23/2017
Was Device Evaluated by Manufacturer? No
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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