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 Date 03/01/2020

Event Type  malfunction  

Event Description

It was reported that the device lost insufflation during the procedure when the cautery device was deployed.Customer does not remember the exact case date, but it was sometime in (b)(6) 2020 during covid.They were able to complete the procedure after restarting the device, and there was no patient injury reported.

Manufacturer Narrative

The previous reportability decision for this event was reversed based on a retrospective review.The affected device has been requested for investigation by the manufacturer.Device was not returned for investigation.Device was serviced by sales executive at customer location.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 ; 4242188247
• MDR Report Key: 18070169
• MDR Text Key: 327381877
• Report Number: 9610617-2023-00361
• 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
• Report Date: 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• 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?: No
• Date Manufacturer Received: 11/12/2020
• 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