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

Model Number 27040XA

Device Problem Material Separation (1562)

Patient Problems Foreign Body In Patient (2687); Unspecified Kidney or Urinary Problem (4503)

Event Date 08/17/2020

Event Type  malfunction  

Manufacturer Narrative

The product has not been returned for evaluation, however; should we receive the item we will file a supplemental filing.

Event Description

Allegedly, during a urology procedure, a piece of the sheath broke off inside the patient's bladder.The doctor retrieved the piece with no harm to the patient; and no other surgical intervention required, procedure was completed.

Manufacturer Narrative

Per the evaluation findings the beak is broken on the distal end and the shaft is dented.The production date code indicated it was manufactured 10 of 2016 it is 4 years old with possible mechanical force/impact to cause breaking of ceramic tip.

• Brand Name: INNER CERAMIC INSULATION TUBE
• Type of Device: RESECTOSCOPE SHEATH, INNER FIXED SHEATH
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm
• MDR Report Key: 10583178
• MDR Text Key: 208765272
• Report Number: 9610617-2020-00107
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• 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
• Device Lot Number: XT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Date Manufacturer Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention