MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ENDOFLATOR 50, W/INTEGRATED SCB MODULE; LAPAROSCOPIC GAS DISTENSION SYSTEM

Model Number UI500

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Bowel Burn (1756)

Event Type  Injury  

Manufacturer Narrative

The investigation is pending.Further information and the concerned product have been requested for the investigation by the manufacturer.

Event Description

As per a manufacturer incident report we received from the factory in (b)(4): it is reported that there was a sudden loss of pressure which resulted in a thermal injury being caused to the patient's small bowel which required suturing.(manufacturer's.Internal complaint #(b)(4)).

Manufacturer Narrative

The assessment of the investigation and test results was completed.The device was found to be in a good condition.An endurance test was performed with the unit, in which no error and no pressure drop (collapse of the cavity) occurred.The unit worked properly and no failure could be detected.The failure description from the customer ("there was a sudden loss of pressure") could not be reproduced.The log-file of the concerned endoflator 50 was also checked.There is no error recorded in the log-file that could lead to a described failure of "a sudden loss of pressure".It was initially assumed that the date of the incident was the date it was reported by the customer, which was (b)(6) 2021.However, the log file of the concerned unit shows that it was not used on this date.Several requests were made to the customer, in order to obtain information about the correct date of the incident and further relevant information for the investigation.However, no information regarding the date nor any other further information was provided.In past events with similar failure descriptions the root cause could be attributed to different user errors, based on the information found in the log-file.But since in this case the log file did not show an error that could explain the described event, and there was no problem found during investigation and testing of the unit, and also the available information is very limited, it is not possible to determine the potential root cause for this incident.

• Brand Name: ENDOFLATOR 50, W/INTEGRATED SCB MODULE
• Type of Device: LAPAROSCOPIC GAS DISTENSION SYSTEM
• 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: anja fair ; 2151 e grand ave; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 13003383
• MDR Text Key: 282226204
• Report Number: 9610617-2021-00091
• Device Sequence Number: 1
• Product Code: FCX
• UDI-Device Identifier: 04048551326657
• UDI-Public: 4048551326657
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K161554
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/08/2022

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
• Device Operator: Health Professional
• Device Model Number: UI500
• Device Catalogue Number: UI500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/29/2021
• Initial Date FDA Received: 12/14/2021
• Supplement Dates Manufacturer Received: 04/07/2022
• Supplement Dates FDA Received: 04/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention