MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CATHETER DEFLECTING MECHANISM

Model Number 27026EF

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

As per manufacturer incident report (b)(4) received from the factory in germany: it was reported that the distal end of the catheter deflecting mechanism broke off during the procedure.The broken off part has not been found and an x-ray was taken without detecting the missing part in the patient.The broken off part could have remained in the patient's body.

Manufacturer Narrative

The affected device was requested for further investigation, but not returned yet.

Manufacturer Narrative

The device was evaluated on july 1st 2022.According to the visual inspection, the shaft is bent and traces of corrosion are visible on the entire instrument.It could be confirmed that the separated part of the insturment is missing.Based on the damage patterns and the investigation results, the most probable root cause is due to incorrect reprocessing, as the instrument was not properly dried.

Event Description

As per additional details provided in the final manufacturer incident report # (b)(4).Received from the factory in germany: the procedure was prolonged by approximately 10 mins as patient drapes, scrub trolley operating table and surrounding area checked.The actual operation results do not deviate from the planned operation results.

• Brand Name: CATHETER DEFLECTING MECHANISM
• Type of Device: CATHETER DEFLECTING MECHANISM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 14653495
• MDR Text Key: 294046176
• Report Number: 9610617-2022-00089
• Device Sequence Number: 1
• Product Code: ODB
• UDI-Device Identifier: 04048551231876
• UDI-Public: 4048551231876
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/11/2022

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: 27026EF
• Device Catalogue Number: 27026EF
• Device Lot Number: PR04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/23/2022
• Initial Date FDA Received: 06/10/2022
• Supplement Dates Manufacturer Received: 07/01/2022
• Supplement Dates FDA Received: 07/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2018
• 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
• Patient Outcome(s): Other