MAUDE Adverse Event Report: STERILMED, INC. APPLIED MEDICAL TROCAR 5MM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED

Model Number 5MM

Device Problems Leak/Splash (1354); Failure to Align (2522)

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

Event Date 06/20/2014

Event Type  malfunction  

Event Description

When trocar was placed in patient, the physician heard leaking; on examination of trocar the top was mis-aligned.Snapped back and continued use on patient.No problems noted.

• Brand Name: APPLIED MEDICAL TROCAR 5MM
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED
• Manufacturer (Section D): STERILMED, INC.; 11400 73rd ave n # 100; maple grove MN 55369
• MDR Report Key: 4116760
• MDR Text Key: 4937891
• Report Number: 4116760
• Device Sequence Number: 1
• Product Code: NLM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 08/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 5MM
• Device Catalogue Number: CTR03
• Device Lot Number: 1747023
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/29/2014
• Event Location: Hospital
• Date Report to Manufacturer: 09/25/2014
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Weight: 82