MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ENDOFLATOR 50

Model Number UI500

Device Problem Device Alarm System (1012)

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

Event Date 06/29/2021

Event Type  malfunction  

Event Description

It was reported that the endoflator stopped working and displayed error message during pediatric laparoscopic surgery.The operator followed the instruction to restart the system several times, which did not resolve the issue.Another back-up unit was utilized to complete the surgery.There was no report of injury to the patient.

Manufacturer Narrative

The previous reportability decision for this event was reversed based on a retrospective review.The reported device was returned and evaluation was performed.The reported complaint was confirmed.The evaluator found the pressure sensor board and the filter board boards were defective.The boards were replaced.The touch screen was also found to have internal debris so it was also replaced.The reported issue will continue to be tracked and trended.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: ENDOFLATOR 50
• Type of Device: ENDOFLATOR 50
• 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 ; 4242188247
• MDR Report Key: 17750272
• MDR Text Key: 323807183
• Report Number: 9610617-2023-00238
• Device Sequence Number: 1
• Product Code: FCX
• 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: Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2017
• 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