MAUDE Adverse Event Report: KARL STORZ SE & CO. KG TUBE,INNER,FIXED.W/CERAMIC; INNER TUBE

Model Number 26055XB

Device Problem Material Integrity Problem (2978)

Patient Problems Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688)

Event Type  malfunction  

Manufacturer Narrative

The customer has not responded to our attempts to gather further information and our service technician was informed the customer will not return the product.

Event Description

The ceramic beak of a sheath broke off while inside a patient.Two broken pieces were retrieved from patient.Second instrument used for observation, no remaining pieces found.No further information is available.

Manufacturer Narrative

The item was evaluated and found the ceramic beak is broken; the shaft is dented; and the stopcock port is rusty.This appears to be maintenance and care.

• Brand Name: TUBE,INNER,FIXED.W/CERAMIC
• Type of Device: INNER TUBE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen ; GM
• MDR Report Key: 10993483
• MDR Text Key: 220979978
• Report Number: 9610617-2020-00142
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04048551275573
• UDI-Public: 4048551275573
• Combination Product (y/n): N
• PMA/PMN Number: K882270
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 26055XB
• Device Lot Number: PQ01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Date Manufacturer Received: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1