MAUDE Adverse Event Report: MEDTRONIC/ COVIDIEN SPACEMAKER PRO; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number SMBTTRNDX

Device Problem Device Slipped (1584)

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

Event Date 01/22/2019

Event Type  malfunction  

Event Description

While using the spacemaker pro access and dissector system for surgery, the inner seal from the 10mm-12mm trocar went into the patient when the 10mm scope was inserted.Trocar was removed by surgeon with no injury to the patient.Event witnessed by rn in the o.R.

• Brand Name: SPACEMAKER PRO
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): MEDTRONIC/ COVIDIEN
• MDR Report Key: 8366642
• MDR Text Key: 137258754
• Report Number: MW5084310
• 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: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

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: SMBTTRNDX
• Device Catalogue Number: (01)10884521545304
• Device Lot Number: PF1420X
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/22/2019
• 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 Outcome(s): Other