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 08/27/2020

Event Type  malfunction  

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 reported issue will continue to be tracked and trended.The event is filed under internal karl storz complaint id: (b)(4).

Event Description

It was reported that the endoflator 50 experienced issue and displayed error messages during laparoscopic cholecystectomy surgery.The system displayed system failure message and no gas warning on monitor with limited access.The engineer had to restart the system 6 or 7 times until the system stopped working.Another system with stryker insufflator on it to complete the surgery.There was no report of injury to the patient; however, the surgeon was losing insufflation which took the surgery much longer than it should be.

• 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: 17750503
• MDR Text Key: 323903802
• Report Number: 9610617-2023-00239
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• 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: 09/08/2020
• Date Manufacturer Received: 08/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2019
• 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