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

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	Malfunction
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.
Additional Manufacturer Narrative
The item in question was returned to the manufacturer.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Investigation revealed that the device functions as intended and the failure described by customer cannot be reproduced.A contamination in the entire pressure control unit was detected.It is possible that the valve got stuck in the actuator due to dirt in the pressure control unit and thus led to an increase in pressure in the patient.However, this could not be verified by the tests.The contamination/dirt is caused by the hospital co2 supply unit.The instruction for use stated that a a functional test for proper operation is required prior to each surgical procedure and in case of any substantial deviations, to inspect the unit by an authorized technician before further use.In addition the device ist about 18 years old and the service manual recommends a preventive maintenance and safety check at least once a year.According to our records the device has not been returned for repair or service since.Review of the complaint history revealed that no similar incidents have been filed against this article number since 2005.Based upon the investigation results, the root cause of the reported issue can be traced back to a usge-related failure.Specifically, it is assumed that the interruption of function was caused by contamination/dirt that was found inside the device.The event is filed under internal karl storz complaint id: (b)(4).

• 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
• Manufacturer Contact: christiane klaiber ; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 16776917
• Report Number: 9610617-2023-00084
• Device Sequence Number: 12477329
• Product Code: HIF
• UDI-Device Identifier: 04048551069264
• UDI-Public: 4048551069264
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K955073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/31/2023

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 Number: 26432020-1
• Device Catalogue Number: 26432020-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2023
• Supplement Date Received by Manufacturer: 04/21/2023; 08/29/2023
• Initial Report FDA Received Date: 04/20/2023
• Supplement Report FDA Received Date: 05/17/2023; 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Sex: Unknown