MAUDE Adverse Event Report: KARL STORZ ENDOVISION ELECTRONIC,C02 ENDOFLATOR W/; LAPAROSCOPIC INSUFFLATOR

Model Number	26430520-1
Medical Device Problem Code	Gradient Increase (1270)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	09/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that four to five minutes after the start of the laparoscopic prostatectomy procedure a sudden increase in insufflation pressure occurred and went up to 28mmhg while the device was set at 12mmhg.The patient had a cardiac arrest and came back after resuscitation treatment of 5-10 minutes.After the patient was stabilized, the medical procedure continued and had been successfully completed.

• Brand Name: ELECTRONIC,C02 ENDOFLATOR W/
• Common Device Name: LAPAROSCOPIC INSUFFLATOR
• Manufacturer (Section D): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• MDR Report Key: 20529474
• Report Number: 2020550-2024-00410
• Device Sequence Number: 9105665
• Product Code: HIF
• UDI-Device Identifier: 04048551068793
• UDI-Public: 04048551068793
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/24/2024
• Report Date (Section F): 10/24/2024

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
• Operator of Device: Health Professional
• Device Model Number: 26430520-1
• Device Catalogue Number: 26430520-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/15/2024
• Event Location: Hospital
• Date Report to Manufacturer: 10/24/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/24/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown