MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY-AMERICA, INC. TUBE,INNER,CERAMIC INSULATION; CERAMIC INSULATION TUBE

Model Number 27040XA

Device Problems Break (1069); Mechanical Problem (1384)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/11/2022

Event Type  malfunction  

Event Description

The event occurred in italy it was reported that during the procedure the ceramic of the inner sheath of the resectoscope was fractured, and the fragment was brought back out of the uterine cavity.No negative impact on the state of health was reported.Internal karl storz reference number: (b)(4).

Manufacturer Narrative

The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.

Manufacturer Narrative

The evaluation conclusion suggests that it is likely that the damage was caused by user error.The shaft has a dent, which could also have been caused by pulling the shaft out at an angle.The ifu points out that items can be damaged by mechanical overload.(example: inner shaft is pulled out of the outer shaft, slightly bent).Furthermore, the ifu points out that the article must be checked for possible damage before each use, since the ceramic beak is sensitive and micro cracks can form here, which can then burst and thus lead to a break.

• Brand Name: TUBE,INNER,CERAMIC INSULATION
• Type of Device: CERAMIC INSULATION TUBE
• Manufacturer (Section D): KARL STORZ ENDOSCOPY-AMERICA, INC.; 2151 e grand ave; el segundo CA 90245 5017
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 15960186
• MDR Text Key: 308080719
• Report Number: 9610617-2022-00327
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04048551076521
• UDI-Public: 4048551076521
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K882270
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/19/2023

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: PR02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2022
• Initial Date FDA Received: 12/12/2022
• Supplement Dates Manufacturer Received: 09/14/2023
• Supplement Dates FDA Received: 09/19/2023
• 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: Unknown
• Patient Sequence Number: 1