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

Model Number UI500

Device Problem Improper Flow or Infusion (2954)

Patient Problem Insufficient Information (4580)

Event Date 11/25/2020

Event Type  Injury  

Manufacturer Narrative

Belated evaluation and reporting of this complaint was done during retrospective review as part of capa 22-0074 corrective action 6.The event is filed under internal karl storz complaint id (b)(4).During the procedure on (b)(6) 2020 (line 945 to 996) it can be seen that the insufflation was switched off and on in very short intervals.Then the device was quickly switched off and on again and the error 322 and 323 occurred.The error 322 and 323 in the log-file caused by a user error, because the unit was restarted during surgery and there was a backflow from the abdomen to the unit during the poweron test.This behavior corresponds to the problem described by the customer.No error occured during the endurance test in the climate chamber for 96h.

Event Description

It was reported that there was event with an "endoflator".According to the information received: unit lost intraabdominal pressure during laparoscopic surgery.Customer tried restarting the unit however this did not help.They finished the surgery with conversion (laparotomy) because second insufflator was not available at the moment.User tried surgery with the unit the following few days and had't observed this problem again." further information is not available.

• Brand Name: ENDOFLATOR 50
• Type of Device: LAPAROSCOPIC INSUFFLATOR
• 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
• MDR Report Key: 17406634
• MDR Text Key: 319900140
• Report Number: 9610617-2023-00659
• Device Sequence Number: 1
• Product Code: FCX
• Combination Product (y/n): N
• Reporter Country Code: HR
• PMA/PMN Number: K161554
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/25/2023

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2021
• Initial Date FDA Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2019
• 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
• Treatment: UI500 ENDOFLATOT 50.
• Patient Outcome(s): Other