MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ELECTRONIC CO2 ENDOFLATOR SCB; LAPAROSCOPIC INSUFFLATOR

Model Number	26430520-1
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pulmonary Emphysema (1832); Skin Disorders (4543)
Date of Event	11/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patients developed pulmonary emphysema during two consecutive operations with an endoflator.Since the patient suffered permanent damage, the case is deemed as reportable.
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.This information is reflected in section d9.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).The second adverse event is handled with case (b)(4).
Additional Manufacturer Narrative
It was reported that the patients developed pulmonary emphysema during two consecutive operations with an endoflator.Since the patient suffered permanent damage, the case is deemed as reportable.The second adverse event is handled with case (b)(4).In the meantime, we have been informed that it is skin emphysema and not pulmonary emphysema.We are not aware of any treatment measures that were necessary as a result of the reported incident.The skin emphysema is reversible and the patient is already recovered.An extended hospital stay was not necessary.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.
Additional Manufacturer Narrative
The item in question was returned to the manufacturer.The evaluation is in progress.The second adverse event is handled with (b)(4).The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Device evaluation: the investigation was finished on (b)(6) 2025.During the manufacturer's technical inspection, the error description provided by the customer was not confirmed.The specified overpressure behaviour is correct.In the event of overpressure in the abdomen, the pressure is released via the electric overpressure valve until the set pressure is reached again.Additionally, an acoustic signal is emitted via the buzzer when excess pressure is present.No failures corresponding to the event were found.Unit works as designed and is in good condition for its age (built in (b)(6) 2008).The ifu inncludes warnings regarding this circumstance on page 6 (see labeling review for reference).The investigations did not reveal a root cause related to the labelling, the device, or its history.All production-related quality checks were passed, and no non-conformities were identified in the device's manufacturing records.The labelling was found to contain adequate instructions and warnings.The complaint history did not reveal any pickup in similar complaints; no trend was identified.The second adverse event is handled with case (b)(4).The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: ELECTRONIC CO2 ENDOFLATOR SCB
• Common Device Name: LAPAROSCOPIC INSUFFLATOR
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 21113920
• Report Number: 1221826-2025-00020
• Device Sequence Number: 7679948
• Product Code: HIF
• UDI-Device Identifier: 04048551068793
• UDI-Public: 04048551068793
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K080852
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/05/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2024
• Supplement Date Received by Manufacturer: 02/07/2025; 03/07/2025; 06/04/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 02/07/2025; 03/11/2025; 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Sex: Unknown