MAUDE Adverse Event Report: KARL STORZ SE & CO. KG THERMOFLATOR SCB; LAPAROSCOPIC INSUFFLATOR

Model Number 26432020-1

Device Problem Inflation Problem (1310)

Patient Problem Pulmonary Emphysema (1832)

Event Date 04/01/2023

Event Type  Injury  

Manufacturer Narrative

The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).

Event Description

It was reported that there were insufflation problems during surgery and pressure check was needed.The surgery was completed successfully.The patient suffered a pulmonary emphysema and needed additional hospitalization after surgery.

• Brand Name: THERMOFLATOR SCB
• Type of Device: LAPAROSCOPIC INSUFFLATOR
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 16776918
• MDR Text Key: 313656127
• Report Number: 2020550-2023-00084
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04048551069264
• UDI-Public: 4048551069264
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26432020-1
• Device Catalogue Number: 26432020-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/19/2023
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Other