MAUDE Adverse Event Report: KARL STORZ SE & CO. KG KARL STORZ ENDOSKOPE INSUFFLATOR UI 500; TUBING/TUBING WITH FILTER, INSUFFLATION, LAPAROSCOPIC

Model Number UI 500

Device Problem No Device Output (1435)

Patient Problem No Code Available (3191)

Event Date 07/28/2020

Event Type  malfunction  

Event Description

During laparoscopic surgery the co2 insufflator stopped working.The surgical case had to stop for a considerable amount of time while a replacement device was brought to the operating room.The storz rep was present and was aware of the issue with the device.Upon our investigation, the storz company is aware of the issues, which are not isolated to this va.Explaining to us that the co2 system, when run along side the bovie cord, receives an electrical interference that triggers the safety auto shut off of the co2.Further, we identified that the issue was not isolated to a single machine or user.After review of these issues, we identified immediate actions to prevent injury to the patient: the heating element for the co2 insufflator will remain disconnected during all laparoscopic cases; positioning of the bovie should be on the opposite side of the patient from the storz system.Storz is providing a software update for the equipment with in the next 2 months.Fda safety report id# (b)(4).

• Brand Name: KARL STORZ ENDOSKOPE INSUFFLATOR UI 500
• Type of Device: TUBING/TUBING WITH FILTER, INSUFFLATION, LAPAROSCOPIC
• Manufacturer (Section D): KARL STORZ SE & CO. KG
• MDR Report Key: 10501540
• MDR Text Key: 206144089
• Report Number: MW5096459
• Device Sequence Number: 1
• Product Code: NKC
• 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: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UI 500
• 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?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 72 YR