MAUDE Adverse Event Report: KARL STORZ SE & CO. KG WORKING ELEMENT, BIPOLAR; WORK GUIDE FOR RIGID ENDOSCOPE

Model Number 26040EB

Device Problems Gas/Air Leak (2946); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Air Embolism (1697)

Event Date 06/11/2021

Event Type  Injury  

Manufacturer Narrative

The affected unit was requested for further investigation but has not returned yet.

Event Description

As per a manufacturer incident report we received from the factory in (b)(6): it was reported that during patient treatment a leakage provoked an air embolism.No further information regarding the state of health is available.

Manufacturer Narrative

The items in question were sent to the manufacturer for further evaluation.According to the results, there is a color difference between the two rings (1st ring karl storz and 2nd ring article number).The inner ring should form a flush surface with the outer ring, this is not the given, which indicates a probably defective spring.When unscrewing the lever, no grease could be detected.That means that no grease was applied after reconditioning.The affected stopcock was corroded and not greased, too.The grease also serves as a sealant; if this is missing, the taps may be leaking.During the check with a leak tester, a pressure loss was confirmed.The most probable root cause is an incorrect reprocessing.The customer will be made aware the reprocessing must be performed as written in chapter "cleaning, disinfection, care and sterilization of karl storz instruments" of the instructions for use (96216003; version 4.1- 07/2021).It is written that joints, threads and gliding surfaces must be lubricated with instrument oil.The stopcock must be lubricated with a special grease.

• Brand Name: WORKING ELEMENT, BIPOLAR
• Type of Device: WORK GUIDE FOR RIGID ENDOSCOPE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• MDR Report Key: 12321069
• MDR Text Key: 266643531
• Report Number: 9610617-2021-00061
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04048551091784
• UDI-Public: 4048551091784
• Combination Product (y/n): N
• PMA/PMN Number: K882270
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 26040EB
• Device Catalogue Number: 26040EB
• Device Lot Number: TQ07
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other