MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ENDOFLATOR® 50; LAPAROSCOPIC GAS DISTENSION SYSTEM

Model Number UI500

Device Problem Crack (1135)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Device is currently under investigation at the factory.Factory has so far only confirmed device's display had sustained mechanical damage.The description of the reported '371' error is: input pressure too low.

Event Description

As per a manufacturer incident report we received from the factory in (b)(4): as reported: "for this ui500, not only the screen is cracked, but also gives error 371, no alarm anymore and doesn't stop giving pressure.Because of that, the patient's heart rate became too low and they had to reanimate him.".

Manufacturer Narrative

Data in section h6 have been corrected to match the evaluation findings.

Manufacturer Narrative

Due to the damage of the screen, the touch was also damaged and the device could not be operated anymore.However, it was still possible to switch the device off or on via the power button.The described error of the customer that the device doesn't stop giving pressure is not comprehensible in the log-file.The co2-gas supply of the device is set to «bottle» but the user uses a «central gas supply».After clarification with the customer, it was confirmed that the central supply is used in the hospital.Therefore the device shows every time that the pressure is too low (message 371), like the user described it.The reason for the patient's heart rate became too low and they had to reanimate him couldn't be determined.After completing replacing the display, the device is working properly.No error occurred during the device endurance test in the climate chamber for 144h.

• Brand Name: ENDOFLATOR® 50
• 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: susie chen ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 11156300
• MDR Text Key: 226314678
• Report Number: 9610617-2021-00005
• Device Sequence Number: 1
• Product Code: FCX
• UDI-Device Identifier: 04048551326657
• UDI-Public: 4048551326657
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K161554
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2021
• 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
• Date Manufacturer Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Male