MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER SHEATH, FOR 27040 SD/SL; RESECTOSCOPE SHEATHS ARE INTENDED FOR CREATION OF AN ACCESS AND WORKING/IRRIGATI

Model Number 27040XA

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/01/2023

Event Type  Injury  

Manufacturer Narrative

The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).

Event Description

It was reported that at end of a procedure, the surgeon moved to use a ball electrode, and noticed the ceramic tip had detached inside the patient and via endoscopic view.Tried to retrieve via several attempts with biopsy forceps but was unable to do so due to swollen tissue occluding vision and anesthetic exposure time.The patient is due to return in 3 weeks' time, surgeon intends to use a stone crusher on the detached part.

Manufacturer Narrative

Additional information about hte event is provided in section b5 of this mdr form.The ceramic beak at the distal end is broken off.Signs of use in the entire article can be seen.Furthermore, the device was manufactured in june 2016.The root cause of the problem is material fatigue caused by a high age and the resulting number of reprocessing.Cracks have probably formed on the ceramic beak which has expanded during use and caused the ceramic tip to burst/break.The event is filed under internal karl storz complaint id: (b)(4).

Event Description

The retrieval was originally sheduled on 15/03 but the surgion was unable to view the missing part at the tim and chose not to proceed furhter with the retrieval.The patient is due to be booked into the (b)(6) hospital where another procedure is intended to use a laser to break up the missing part.The date of the planned procedure was not provided to kst.

• Brand Name: INNER SHEATH, FOR 27040 SD/SL
• Type of Device: RESECTOSCOPE SHEATHS ARE INTENDED FOR CREATION OF AN ACCESS AND WORKING/IRRIGATI
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• 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: 16566637
• MDR Text Key: 311513468
• Report Number: 9610617-2023-00056
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K882270
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 27040XA
• Device Catalogue Number: 27040XA
• Device Lot Number: OT08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2016
• 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 Outcome(s): Required Intervention