MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ELECTRONIC C02 ENDOFLATOR* SCB

Model Number	26430520-1
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product has not yet been returned for investigation.The factory's report noted that no complaints for this device with similar failure description were received.Additionally, no similar complaints for this device have been received in the u.S.
Event or Problem Description
As per a manufacturer incident report we received from the factory in germany: following insufflation, cardiac of the patient (living patient).Use of the same device in the afternoon, cardiac arrest avoided.
Additional Manufacturer Narrative
Data in section h6 have been corrected to match the evaluation findings.
Additional Manufacturer Narrative
All tests done with the device were successful passed.No deviation found.Based on incident description, the user used of the same device in the afternoon and cardiac arrest avoided.No indication for a material or manufacturing related issue was found during the investigation.Since there is no link between the device and patient harm, this case is non reportable.

• Common Device Name: ENDOFLATOR
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 10793585
• Report Number: 9610617-2020-00119
• Device Sequence Number: 2875229
• Product Code: HIF
• UDI-Device Identifier: 04048551068793
• UDI-Public: 4048551068793
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 26430520-1
• Device Catalogue Number: 26430520-1
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 10/12/2020; 08/10/2022
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 08/08/2022; 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2019
• Is the Device Labeled for Single Use? (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: Other
• Patient Sex: Unknown