MAUDE Adverse Event Report: KRONNER MEDICAL KRONNER MEDICAL; KRONNER SIDE-KICK

Model Number KRONNER 5000

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Death (1802); Embolus (1830)

Event Date 12/30/2016

Event Type  Death  

Event Description

(b)(6) was a (b)(6) female who underwent an elective robotic hysterectomy on (b)(6) 2016.Intraoperatively, the pt had a massive nitrogen air embolism to the heart.(b)(6) had a cardiac arrest and cpr/acls protocol initiated.Despite heroic measures taken to remove the air.(b)(6) was declared brain dead on (b)(6) 2017 life support was withdrawn and pt expired at 1633 on (b)(6) 2017.Just prior to starting the robotic hysterectomy, it was noted that after the vcare uterine manipulator was placed and the nitrogen gas was turned on to the kronner side-kick, a hissing sound was heard and it was noted that the tubing was improperly connected.The gas was immediately turned off within seconds.The tubing that should have been connected to the port for the kronner side-kick had been connected to the chromotubation port to the vcare uterine manipulator instead.There was no warning label on alert to distinguish the two ports.The tubing intended for the kronner side-kick also fit the port to the vcare device.

• Brand Name: KRONNER MEDICAL
• Type of Device: KRONNER SIDE-KICK
• Manufacturer (Section D): KRONNER MEDICAL; roseburg OR
• MDR Report Key: 6233887
• MDR Text Key: 64262822
• Report Number: 6233887
• Device Sequence Number: 1
• Product Code: LKF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KRONNER 5000
• Device Catalogue Number: KPIH-5500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/05/2017
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/05/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/09/2017
• 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
• Treatment: KRONNER MEDICAL TUBING: LOT #H1030188, ; LOT #201303091, REF #60-6085-202, EXP: 03/09/2018; REF # H08-03059, EXP: 09/30/2019; VCARE UTERINE MANIPULATOR: SIZE MEDIUM,
• Patient Outcome(s): Death
• Patient Age: 58 YR
• Patient Weight: 73