MAUDE Adverse Event Report: KARL STORZ SE & CO. KG 26FR FIXED INNER TUBE W/CERAMIC INSULATION; RESECTOSCOPE INNER SHEATH TUBE

Model Number 27040XA

Device Problems Break (1069); Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Device is in transit to the factory.Device not received so far; therefore, no investigation possible as of yet.

Event Description

As per a manufacturer incident report we received from the factory in (b)(6): as reported: "during a rtu, a part of the 27040xa (the ceramic tip) was detached within the patient, resulting following open surgery.".

Manufacturer Narrative

The instrument was manufactured in (b)(6) 2016.Upon examination, it can be seen that the distal tip was broken and has no discoloration on a broken surface; there is some rust on the stopcock.Multiple mechanical damages observed in the metal tubing such as bent, dented.The root cause of breakage is most likely due to mechanical overload i.E.Use error.No indication for a material or manufacturing related issue was found during the investigation.Ifu includes warning of risk or injury: overloading the instrument by exerting too much force may cause the medical device to break, bend and malfunction, and consequently injure the patient.

• Brand Name: 26FR FIXED INNER TUBE W/CERAMIC INSULATION
• Type of Device: RESECTOSCOPE INNER SHEATH TUBE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• MDR Report Key: 12110272
• MDR Text Key: 268204719
• Report Number: 9610617-2021-00053
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27040XA
• Device Catalogue Number: 27040XA
• Device Lot Number: PT03
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/04/2021
• Initial Date FDA Received: 07/02/2021
• Supplement Dates Manufacturer Received: 06/04/2021
• Supplement Dates FDA Received: 08/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other