MAUDE Adverse Event Report: STERILMED, INC.; ENDOSCOPIC TROCAR

Model Number APPC0R37

Device Problem Leak/Splash (1354)

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

Event Date 07/29/2014

Event Type  malfunction  

Event Description

It was reported that during a laparoscopic sleeve the device leaked from the port after some use when a 5mm grasper was inserted into the sleeve.Pneumoperitoneum was lost and the device was replaced.There was no patient injury.Additional info was requested, but no additional was provided.A supplemental report will be sent if the additional information is received.

Manufacturer Narrative

Final device investigation found that the device with the insufflation port cracked.Upon evaluation a tear was found inside the sleeve on the deep cone seal.The device the was pressure tested and showed signs of leaking.The device history record was reviewed, and no discrepancies were noted.As each device is inspected for cracks and tears prior to release, no conclusion could be made as to what may have caused the reported event.

• Brand Name: NA
• Type of Device: ENDOSCOPIC TROCAR
• Manufacturer (Section D): STERILMED, INC.; maple grove MN
• Manufacturer Contact: tricia schrater ; 11400 73rd ave. north; maple grove, MN 55369 ; 7634883211
• MDR Report Key: 4062663
• MDR Text Key: 16559645
• Report Number: 2134070-2014-00154
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2015
• Device Model Number: APPC0R37
• Device Catalogue Number: C0R37
• Device Lot Number: 1777978
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/31/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• 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