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

Model Number APPCTS22

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2014

Event Type  malfunction  

Event Description

It was reported that small pieces of a black substance were noted to be falling out of the sleeves of two devices into the abdomen.The small black pieces were removed without incident.It was believed that they originated from the diaphragm of the device sleeves and that instruments were inserted and removed during the procedure.It also was believed that the procedure was a laparoscopic sleeve gastrectomy.Another device was used to complete the procedure.There was no patient injury.Black rubber-like fleck were observed in the sleeves following the procedure.See related mdr 2134070-2015-00013.

Manufacturer Narrative

The device was received by the manufacturer and is being evaluated.A supplemental report will be sent when the evaluation is complete.

Manufacturer Narrative

Final device investigation found that the device was returned with the inner black seal which covers the iris torn and pieces of the seal returned with the device.The pieces and the remaining seal were found to be pliable, not brittle.The device was not pressure tested due to its returned condition.The device history record was reviewed, and no discrepancies were noted.

• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED
• Manufacturer (Section D): STERILMED, INC.; 11400 73rd ave n; maple grove MN
• Manufacturer Contact: patricia kaufman ; 5010 cheshire parkway, suite 2; plymouth, MN 55446 ; 7634888321
• MDR Report Key: 4636010
• MDR Text Key: 16181503
• Report Number: 2134070-2015-00012
• Device Sequence Number: 1
• Product Code: NLM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/25/2015

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: 08/31/2015
• Device Model Number: APPCTS22
• Device Catalogue Number: APPCTS22
• Device Lot Number: 1790074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2015
• Initial Date FDA Received: 03/26/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2014
• 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