MAUDE Adverse Event Report: SURGIQUEST AIRSEAL PORT-SURGIQUEST; TROCAR

Model Number IAS12-120

Device Problem Break (1069)

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

Event Date 11/16/2015

Event Type  malfunction  

Event Description

During surgery, (robotic lysis of adhesions, cholecystectomy, and loop duodenal switch), upon removal of a 12-mm trocar, it was noted that a small piece of the trocar was broken.An attempt was made to identify the piece of the trocar that broke off without success.

• Brand Name: AIRSEAL PORT-SURGIQUEST
• Type of Device: TROCAR
• Manufacturer (Section D): SURGIQUEST
• MDR Report Key: 5273211
• MDR Text Key: 32952266
• Report Number: MW5058360
• Device Sequence Number: 1
• Product Code: HIF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/02/2015

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: IAS12-120
• Device Catalogue Number: IAS12-120
• Device Lot Number: #507-15
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/02/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR