MAUDE Adverse Event Report: STERILMED, INC.; LAPAROSCOPE, REPROCESSED

Model Number APPCOR37

Device Problem Leak/Splash (1354)

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

Event Date 09/22/2014

Event Type  malfunction  

Event Description

It was reported that during a laparoscopic sleeve gastrectomy the bladder valve leaked.A second device was brought in for the case and it also leaked in the case and it also leaked in the same manner but "not as bad." a third device from another manufacturer was used to complete the procedure.There was no patient injury.The second device was not kept.This report is being filed for the first device.See relate mfr.Report #2134070-2014-00180.

Manufacturer Narrative

The device was returned to the manufacturer and is currently undergoing device evaluation.A supplemental report will be sent when the evaluation is complete.

• Brand Name: NA
• Type of Device: LAPAROSCOPE, REPROCESSED
• Manufacturer (Section D): STERILMED, INC.; maple grove MN
• Manufacturer Contact: tricia shrater ; 11400 73rd ave. north; maple grove, MN 55369 ; 7634883211
• MDR Report Key: 4188065
• MDR Text Key: 5027443
• Report Number: 2134070-2014-00179
• 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: 09/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2015
• Device Model Number: APPCOR37
• Device Catalogue Number: COR37
• Device Lot Number: 1789001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/23/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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