MAUDE Adverse Event Report: SURGIQUEST AIRSEAL 12MM OBTURATOR; TROCAR

Model Number IAS12-100LPI

Device Problem Torn Material (3024)

Patient Problem Cancer (3262)

Event Date 05/07/2018

Event Type  Injury  

Event Description

Airseal blue rubber casket or seal tore in half during procedure.We remove from pelvis.Davinci assisted prostatectomy.Dates of use: (b)(6) 2018 9:30 - 11:00.Diagnosis or reason for use: prostate cancer.Is the product over-the-counter: no.

• Brand Name: AIRSEAL 12MM OBTURATOR
• Type of Device: TROCAR
• Manufacturer (Section D): SURGIQUEST
• MDR Report Key: 7502330
• MDR Text Key: 108092350
• Report Number: MW5077116
• 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: Nurse
• Type of Report: Initial
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: IAS12-100LPI
• Device Catalogue Number: IAS12-100LPI
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR