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

Model Number UI500

Device Problem Pressure Problem (3012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that during a procedure (case type and case date not provided), the gas stopped flowing 2-3 times during use.They were able to complete the procedure with a back-up unit with no adverse affects on the patient.

Manufacturer Narrative

The device will be forwarded to the manufacturing site for investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).

Manufacturer Narrative

Per evaluation result by the manufacturer: product inspection: the customer message "the gas stopped flowing 2-3 times during use" could not be verified by the system engineering department.The colleagues confirmed the following failure instead: "after 78h in the climate chamber with 35°c the temperature sensor b800 (lm75aim) on the control board (storz mat.-no.: 1981691-2 rev.Ad) occurred once an electronic error 382.No further errors occurred during further testing.The error communicated by the customer that the supply pressure collapses did not occur either." the behavior that the customer has reported can be traced in the log file with the messages 362, 363, 371, and 373.However, this is quite normal behavior and can occur when the insufflation is started and the supply hose is blocked, kinked or the stopcock on the co2 bottle is not fully open or the co2-bottle got empty.Operating hours: 133 hours in total since manufacturing switch on procedures: 45x (3x fast restarts with an off-time <90 seconds until the device is turned on again).Date of incident was not communicated by customer.According to the log-files, it can be assumed that the incident occurred on 18.11.2023.On this date the co2-bottle got three times empty (log-file entry with message 373) and the insufflation was stopped during op.Conclusion and root cause determination: most probable root cause: operator error.The customer message "the gas stopped flowing 2-3 times during use" could not be verified.The error communicated by the customer that the supply pressure collapses did not occur.The behaviour that the customer has reported can be traced in the log-file with the messages 362, 363, 371 and 373.The date of incident was not communicated by customer.According to the log-files, it can be assumed that the incident occurred on 18.11.2023.There were 3 log-file entry with message 371 and 373.Error code 373 indicates e.G.An empty co2-bottle.If this occurs the gas insufflation stops during operation.Error code 371 informs about an bottle pressure below 10 bars.Error code 363 indicates the need to exchange the co2 gas bottle because the pressure is less than 20 bar.Error code 362 indicates a bottle preesure less than 30bar which means the need for organizing a spare gas bottle to be able to exchange them.Correction / corrective action: no corrective actions necessary as there is no critical and/or systematic deviation found during investigation.This event is filed under internal complaint id (b)(4).

• 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; 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 90245-5017
• MDR Report Key: 18319617
• MDR Text Key: 330949780
• Report Number: 9610617-2023-00382
• Device Sequence Number: 1
• Product Code: FCX
• UDI-Device Identifier: 04048551326657
• UDI-Public: 4048551326657
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161554
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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