MAUDE Adverse Event Report: STERILMED, INC.

Model Number APPCTR73

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/16/2014

Event Type  malfunction  

Event Description

It was reported that during a robotic laparoscopic prostatectomy one device leaked and a second device fell apart during the surgery, with the rubber inner seal and small piece of plastic falling into the abdomen.The pieces were retrieved.Another device was used to complete the case.The case took longer.There was no pt injury.This report is for the first device.

Manufacturer Narrative

The device was received by the mfr, and the eval is in progress.A follow-up report will be sent when the eval is complete.

• 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 Key: 3879829
• MDR Text Key: 4590511
• Report Number: 2134070-2014-00035
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/16/2014

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 Model Number: APPCTR73
• Device Catalogue Number: CTR73
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/01/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2014
• Initial Date FDA Received: 02/11/2014
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1