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

Model Number 27040XA

Device Problem Mechanical Problem (1384)

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.Our evaluation found the distal end ceramic beak appeared to be broken off in pieces, and, with a burn mark on the inner surface of the remaining beak and also the shaft has a big dent.We cannot determine when the inner tube was shipped to the customer, there is no history of a sale in our system.This damage most likely was from mechanical force.

Event Description

Per customer, the ceramic tip broke off during a surgical procedure and the broken pieces had to be retrieved from the patients body.

• Brand Name: TUBE,INNER,CERAMIC INSULATION
• Type of Device: INNER TUBE
• 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: susie chen ; 2151 east grand avenue; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 9484759
• MDR Text Key: 194176650
• Report Number: 9610617-2019-00120
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04048551076521
• UDI-Public: 4048551076521
• Combination Product (y/n): N
• PMA/PMN Number: K882270
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature,other
• Type of Report: Initial
• Report Date: 11/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 27040XA
• Device Lot Number: NS04
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2017
• 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