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

Model Number	26040EB
Medical Device Problem Codes	Gas/Air Leak (2946); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	06/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected unit was requested for further investigation but has not returned yet.
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 9610617-2021-00061
• Device Sequence Number: 11752873
• Product Code: HIH
• UDI-Device Identifier: 04048551091784
• UDI-Public: 4048551091784
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K882270
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 26040EB
• Device Catalogue Number: 26040EB
• Device Lot Number: TQ07
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/23/2021
• Supplement Date Received by Manufacturer: 07/23/2021
• Initial Report FDA Received Date: 08/13/2021
• Supplement Report FDA Received Date: 11/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other