MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY-AMERICA, INC. KARLSTORZ ENDOSKOPE INSUFFLATOR UI 500; TUBING/TUBING WITH FILTER, INSUFFLATION, LAPAROSCOPIC

Model Number UI 500

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 07/28/2020

Event Type  malfunction  

Event Description

During laparoscopic surgery the co2 insufflator stopped working.Fda safety report id# (b)(4).

• Brand Name: KARLSTORZ ENDOSKOPE INSUFFLATOR UI 500
• Type of Device: TUBING/TUBING WITH FILTER, INSUFFLATION, LAPAROSCOPIC
• Manufacturer (Section D): KARL STORZ ENDOSCOPY-AMERICA, INC.
• MDR Report Key: 10384535
• MDR Text Key: 202416487
• Report Number: MW5095967
• Device Sequence Number: 1
• Product Code: NKC
• 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: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• 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