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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG THERMOFLATOR SCB; LAPAROSCOPIC INSUFFLATOR
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KARL STORZ SE & CO. KG THERMOFLATOR SCB; LAPAROSCOPIC INSUFFLATOR Back to Search Results
Model Number 26432020-1
Medical Device Problem Code Inflation Problem (1310)
Health Effect - Clinical Code Pulmonary Emphysema (1832)
Date of Event 04/01/2023
Type of Reportable Event Serious Injury
Additional 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 or Problem 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.
 
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Brand Name
THERMOFLATOR SCB
Common Device Name
LAPAROSCOPIC INSUFFLATOR
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
tuttlingen, 78532
GM  78532
MDR Report Key16776918
Report Number2020550-2023-00084
Device Sequence Number6858822
Product Code HIF
UDI-Device Identifier04048551069264
UDI-Public4048551069264
Combination Product (Y/N)N
Initial Reporter CountryIT
Number of Events Summarized1
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) 04/20/2023
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 Number26432020-1
Device Catalogue Number26432020-1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/19/2023
Event Location Hospital
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date04/20/2023
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention; Other;
Patient SexUnknown
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