MAUDE Adverse Event Report: COVIDIEN COVIDIEN; TROCAR

Model Number OMS-T10BT

Device Problem Inflation Problem (1310)

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

Event Date 04/11/2017

Event Type  malfunction  

Event Description

Patient was scheduled for diagnostic laparoscopy and exploration left groin at 08:30.Surg tech attempted to inflate balloon on blunt tip trocar but it failed to inflate before being used on patient or being handled to physician.Three other trocars were opened and also failed to inflate.One trocar from another lot number was located on our shelf and opened for use on case.Two other trocars with failure lot number removed by operating room staff.

• Brand Name: COVIDIEN
• Type of Device: TROCAR
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 6493002
• MDR Text Key: 72943830
• Report Number: MW5069081
• Device Sequence Number: 1
• Product Code: DRC
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/12/2017
• 4 Devices were Involved in the Event: 1 2 3 4

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: OMS-T10BT
• Device Lot Number: #P6K0782X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/12/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 33 YR