MAUDE Adverse Event Report: STERILMED, INC.; LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED

Model Number ETHB5LT

Device Problems Material Fragmentation (1261); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/03/2016

Event Type  malfunction  

Manufacturer Narrative

The device has not yet been returned to the manufacturer at the time of this report, but is anticipated.A supplemental form will be sent once the evaluation is completed if the device is returned.The device history report was reviewed and no discrepancies were found.

Event Description

It was reported that a foreign object fell from the device into the patient abdomen during a procedure.The object was described as looking like a black o-ring or gasket.It was reported that the foreign piece was removed from the patient and no injury or consequence resulted.

• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED
• Manufacturer (Section D): STERILMED, INC.; 11400 73rd ave n; maple grove MN
• Manufacturer Contact: jason anderson ; 5010 cheshire parkway; suite 2; plymouth, MN 55446 ; 7634888348
• MDR Report Key: 5666225
• MDR Text Key: 45489899
• Report Number: 2134070-2016-00029
• Device Sequence Number: 1
• Product Code: NLM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052299
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/04/2016

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 Date: 01/21/2017
• Device Model Number: ETHB5LT
• Device Catalogue Number: ETHB5LT
• Device Lot Number: 1921550
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2016
• Initial Date FDA Received: 05/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1