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 Date 02/01/2019

Event Type  malfunction  

Manufacturer Narrative

The customer has not responded to our attempts to gather further information.Our evaluation findings found the distal end ceramic beak has a piece broken off and also is burnt.The shaft has a big dent and the stopcock is bent and moldy, which it will not move at all.The proximal end seal is dented and worn.

Event Description

During a resection of the prostate procedure, a piece broke off into the patient's bladder.It was retrieved immediately without harm to the patient.

• 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
• MDR Report Key: 8457006
• MDR Text Key: 140133517
• Report Number: 9610617-2019-00033
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04048551076521
• UDI-Public: 4048551076521
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K882270
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27040XA
• Device Lot Number: NS07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2019
• Date Manufacturer Received: 02/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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