MAUDE Adverse Event Report: COVIDIEN AUTOSUTURE BLUNT TIP TROCAR 12MM

Model Number OMS-T12BT

Device Problem Material Rupture (1546)

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

Event Date 03/27/2017

Event Type  malfunction  

Event Description

Balloon at tip of 12mm blunt tip trocar ruptured during use (robotic-assisted laparoscopic prostatectomy, extra peritoneal approach, bladder neck resection with bladder neck reconstruction, robotic-assisted laparoscopic bilateral extended pelvic lymph node dissection, robotic-assisted laparoscopic anterior and posterior reconstruction of the rhabdosphincter).

• Brand Name: AUTOSUTURE BLUNT TIP TROCAR 12MM
• Type of Device: TROCAR
• Manufacturer (Section D): COVIDIEN; mansfield MA 02048
• MDR Report Key: 6521843
• MDR Text Key: 73900995
• Report Number: MW5069320
• Device Sequence Number: 1
• Product Code: DRC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/24/2017

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 Expiration Date: 08/31/2018
• Device Model Number: OMS-T12BT
• Device Lot Number: P5H0069X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2017
• 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: 64 YR
• Patient Weight: 85