MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CORP KII FIOS FIRST ENTRY 5 MM TROCAR

Catalog Number CFF03

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2011

Event Type  malfunction  

Event Description

Tip of trocar broke off as it was removed from the abdomen.Retrieved tip.No patient harm.

• Brand Name: KII FIOS FIRST ENTRY 5 MM TROCAR
• Type of Device: TROCAR
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES CORP; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5334241
• MDR Text Key: 34651279
• Report Number: 5334241
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: CFF03
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/11/2015
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 12/11/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 53 YR