MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER CERAMIC TUBE; 26FR. FIXED INNER TUBE

Model Number 27040XA

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2022

Event Type  malfunction  

Manufacturer Narrative

The manufacturer's internal number is (b)(4).The facility site is undetermined and therefore product request could not be completed.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.

Event Description

It was reported that there was an issue with the product 27040xa ceramic inner tube.According to the information received via medwatch mw5113666 the plastic tip of resectoscope broke off in a patient while undergoing a transurethral resection of prostate.Plastic piece retrieved under direct vision.No injury to patient.The tip of the inner sheath of the resectoscope broke.This happened not during active resection, but a crack was heard after irrigation was started when the sheath was replaced post draining chips from the bladder.The case was completed with a second set.No account or contact information has been provided for additional information regarding patient information.

Manufacturer Narrative

The manufactures internal number is (b)(4).Additional investigation product report findings: based on similar complaints in the past, user error is assumed.Based on the damage shown above, the breakage of the ceramic beak may have been caused by pulling the inner shaft out of the outer shaft at an angle.When the inner shaft is pulled out of the outer shaft at an angle this presses the ceramic against the outer shaft and can cause it to break.In addition, the ifu points out that the ceramic beak should be checked for damage before use.

• Brand Name: INNER CERAMIC TUBE
• Type of Device: 26FR. FIXED INNER TUBE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.-karl-storz -strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo
• MDR Report Key: 16117527
• MDR Text Key: 308266942
• Report Number: 9610617-2022-00336
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/30/2023

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: UO09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/12/2022
• Initial Date FDA Received: 01/06/2023
• Supplement Dates Manufacturer Received: 01/27/2023
• Supplement Dates FDA Received: 05/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male