MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CATHETER DEFLECTING MECHANISM; RIGID ENDOSCOPE WORKING GUIDE

Model Number 27026E

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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)).The examination of item 27026e lot xyo1 revealed the following: a crack is visible in the joint at the distal end and corrosion is also visible.In addition, heavy contamination was found in the tap housing and on the tap driver and a lack of lubrication with special grease, which impairs the function of the tap driver.There are also strong traces of corrosion inside the steering housing (after dismantling the steering wheels).Here, the penetration of moisture should be prevented by the rubber seals.Conspicuous here was that no spring or ball could be detected during disassembly.On one side of the shaft, in the area of the screw connection (marten screw in steering wheel), there is spalling/soiling on the shaft.Due to the defects listed above, it is concluded that the user is at fault, faulty reconditioning: corrosion marks can be seen on the entire instrument, including inside the housing.Corrosion can only occur here if the steering wheels have been pulled out by force.This allows moisture to get into the housing.The absence of the spiral spring also confirms that the steering wheels have been removed.Due to the corrosion on the shaft and by pulling the steering wheels apart (they are fastened with 2 screws), the surface has (presumably) flaked off.

Event Description

It was reported that there was event with a "catheter deflecting mechanism".According to the information received, during a check before application it was found that the cathether deflecting mechanism wheel loose.Further information is not available.

• Brand Name: CATHETER DEFLECTING MECHANISM
• Type of Device: RIGID ENDOSCOPE WORKING GUIDE
• 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: 17259494
• MDR Text Key: 318468468
• Report Number: 9610617-2023-00916
• Device Sequence Number: 1
• Product Code: ODB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K943697
• 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: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27026E
• Device Catalogue Number: 27026E
• Device Lot Number: XV01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/27/2021
• Initial Date FDA Received: 07/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2014
• 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