MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER CERAMIC TUBE; 26FR. FIXED INNER TUBE

Model Number 27040XA

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 12/20/2019

Event Type  Injury  

Manufacturer Narrative

Health (b)(6) received the filing in 2022.Limited details were provided.Product was not returned for evaluation.

Event Description

During an endoscopic procedure the insulated ceramic beak broke inside the patient, there were no known health consequences to the patient.

• Brand Name: INNER CERAMIC TUBE
• Type of Device: 26FR. FIXED INNER TUBE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.-karl-storz -strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo
• MDR Report Key: 14700488
• MDR Text Key: 294155188
• Report Number: 9610617-2022-00094
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04048551076521
• UDI-Public: 4048551076521
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K882270
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/16/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: 27040XA
• Device Catalogue Number: 27040XA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2022
• Initial Date FDA Received: 06/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other